Acetaminophen / Codeine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hi-Tech Pharmacal Co., Inc. (2015-03-16)
Oldest Current Product
1981-07-22
License(s)
ANDA
RxNORM
ORAL SOLUTION\ACETAMINOPHEN:CODEINE
FDAOB
ORAL\SOLUTION\ACETAMINOPHEN: CODEINE PHOSPHATE
ORAL\TABLET\ACETAMINOPHEN: HYDROCODONE BITARTRATE
SPL Active
ORAL\LIQUID\ACETAMINOPHEN: CODEINE PHOSPHATE
ORAL\SOLUTION\ACETAMINOPHEN: CODEINE PHOSPHATE
SPL Moiety
ORAL\LIQUID\ACETAMINOPHEN: CODEINE ANHYDROUS
ORAL\SOLUTION\ACETAMINOPHEN: CODEINE
ORAL\SOLUTION\ACETAMINOPHEN: CODEINE ANHYDROUS

product(s) by strength(s)

acetaminophen 24 mg/ml / codeine phosphate 2.4 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210504ANDAPharmaceutical Associates, Inc.1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTIONANDA08750895ac6875-6b14-4cde-8efb-80704e39b8d8
2006039013ANDAQualitest Pharmaceuticals2011-11-10ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTIONANDA091238e1da6cd0-97fb-4dc4-b754-485ff364e35f
3466720561ANDAMikart, Inc.1992-10-27ACETAMINOPHEN, CODEINE PHOSPHATEORALLIQUIDANDA0894507bca1d24-a317-44c4-8db2-68030eb961ed
4503830079ANDAHi-Tech Pharmacal Co., Inc.1996-04-26ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTIONANDA04011983a536d8-385d-46ed-9cd2-47b7efe96ccf
5604320245ANDAMorton Grove Pharmaceuticals, Inc.1981-07-22ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTIONANDA087006d2b39d16-03c2-4448-bcce-14d66d2069cc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340975ANDAApotheca, Inc2009-09-04ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION503830079ANDA040119ccfaceb3-b3d3-4400-bae8-83e2ee272021
2178560079ANDAAtlantic Biologicals Corps1996-04-26ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION503830079ANDA040119aa4ad524-fca4-40c7-b7e2-31772e6d4839
3216950547ANDARebel Distributors Corp1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA0875082f92c67b-f324-4c4e-89fd-1e0f8af96fba
4332610470ANDAAidarex Pharmaceuticals Llc1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA08750859c33fd9-ef24-4893-b904-3e5f8cea58c7
5430630139ANDAPd-Rx Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA0407469b3f274c-e7d8-4c67-aa22-bf5aa62064cc
6500900215ANDAA-S Medication Solutions Llc1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA08750831cce165-fdfb-434c-83c2-fcc7709c03f4
7500900216ANDAA-S Medication Solutions Llc1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA0875080995dd90-e20c-4733-a4ec-5eed257d62e5
8545691001ANDAA-S Medication Solutions Llc1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA0875084f5ca56d-807c-4111-8267-cc9035e1a031
9545698336ANDAA-S Medication Solutions Llc1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA0875086f6dc6c1-8f0d-4ca3-a0df-ab9103f73f6d
10548680378ANDAPhysicians Total Care, Inc.2004-10-19ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA0875089bf3c04c-22d8-493f-8dbd-c10613042ee5
11551549415ANDACardinal Health2011-06-10ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA087508b373acb5-670b-43d1-8afd-a2f8d52c015b
12551549442ANDACardinal Health2011-06-10ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA0875082abec441-3eac-4c0e-a05a-369a1ef0e51f
13631870291ANDAProficient Rx Lp1981-08-21ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION001210504ANDA087508b14edc3f-4490-4ad1-ad72-185b627a033c
14672960651ANDARedpharm Drug Inc.1996-04-26ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION503830079ANDA0401197ed43443-45fc-4e72-b3be-6503b4c1c637
15687880076ANDAPreferred Pharmaceuticals, Inc.2011-03-01ACETAMINOPHEN, CODEINE PHOSPHATEORALSOLUTION503830079ANDA040119afde197c-3207-4ca5-bfa4-72099e9be419

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040084HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMALLINCKRODT CHEMICAL INC1995-06-01ANDA040084_001, ANDA040084_002, ANDA040084_003, ANDA040084_004Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
2ANDA040094HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1995-09-29ANDA040094_001, ANDA040094_002, ANDA040094_003, ANDA040094_004Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
3ANDA040098ACETAMINOPHEN AND CODEINE PHOSPHATETrueDAVA PHARMACEUTICALS INC1996-09-20ANDA040098_001
4ANDA040099NORCOWATSON LABORATORIES1997-06-25ANDA040099_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
5ANDA040100LORTABTrueUCB INC1996-01-26ANDA040100_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
6ANDA040117VICODIN HPTrueABBVIE INC1996-09-23ANDA040117_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
7ANDA040119ACETAMINOPHEN AND CODEINE PHOSPHATEHI TECH PHARMACAL CO INC1996-04-26ANDA040119_001
8ANDA040122HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1996-03-04ANDA040122_001, ANDA040122_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
9ANDA040123HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1996-03-04ANDA040123_001, ANDA040123_002, ANDA040123_003, ANDA040123_004Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
10ANDA040134HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUCB INC1996-11-21ANDA040134_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
11ANDA040143HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-02-22ANDA040143_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
12ANDA040144HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-02-22ANDA040144_001, ANDA040144_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
13ANDA040148HYDROCODONE BITARTRATE AND ACETAMINOPHENACTAVIS LABORATORIES FL INC1997-02-14ANDA040148_001, ANDA040148_002, ANDA040148_003, ANDA040148_004, ANDA040148_005Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
14ANDA040149HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueSANDOZ INC1997-01-27ANDA040149_001, ANDA040149_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
15ANDA040155HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1997-04-14ANDA040155_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
16ANDA040157HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1996-04-12ANDA040157_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
17ANDA040201HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMALLINCKRODT CHEMICAL INC1998-02-27ANDA040201_001, ANDA040201_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
18ANDA040210HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUCB INC1997-08-13ANDA040210_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
19ANDA040236HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1997-09-25ANDA040236_001, ANDA040236_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
20ANDA040240HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1997-11-26ANDA040240_001, ANDA040240_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
21ANDA040248HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC2000-04-28ANDA040248_001, ANDA040248_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
22ANDA040280HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS LLC1998-09-30ANDA040280_001, ANDA040280_002, ANDA040280_003Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
23ANDA040281HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS LLC1998-09-30ANDA040281_001, ANDA040281_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
24ANDA040288ZYDONETrueVINTAGE PHARMACEUTICALS LLC1998-11-27ANDA040288_001, ANDA040288_002, ANDA040288_003Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
25ANDA040307HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-07-26ANDA040307_001, ANDA040307_002, ANDA040307_003, ANDA040307_004Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
26ANDA040308HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-07-26ANDA040308_001, ANDA040308_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
27ANDA040309HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC2000-07-26ANDA040309_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
28ANDA040355HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS INC2000-05-31ANDA040355_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
29ANDA040356HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC2000-05-31ANDA040356_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
30ANDA040358HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC2000-05-31ANDA040358_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
31ANDA040400HYDROCODONE BITARTRATE AND ACETAMINOPHENMALLINCKRODT INC2000-07-26ANDA040400_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
32ANDA040405ANEXSIA 7.5/325MALLINCKRODT INC2000-09-08ANDA040405_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
33ANDA040409ANEXSIA 5/325MALLINCKRODT INC2000-10-20ANDA040409_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
34ANDA040432HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2003-01-22ANDA040432_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
35ANDA040464HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-10-23ANDA040464_001, ANDA040464_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
36ANDA040468ANEXSIATrueMALLINCKRODT INC2002-10-31ANDA040468_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
37ANDA040469HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-10-25ANDA040469_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
38ANDA040473HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-11-06ANDA040473_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
39ANDA040474HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2003-01-02ANDA040474_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
40ANDA040476HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-10-23ANDA040476_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
41ANDA040477HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-11-06ANDA040477_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
42ANDA040478HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2002-11-08ANDA040478_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
43ANDA040490HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2003-05-21ANDA040490_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
44ANDA040493HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2003-05-28ANDA040493_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
45ANDA040494HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2003-05-28ANDA040494_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
46ANDA040495HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2003-05-28ANDA040495_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
47ANDA040556HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2004-06-23ANDA040556_001, ANDA040556_002Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
48ANDA040655HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS INC2006-01-19ANDA040655_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
49ANDA040656HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS INC2006-01-19ANDA040656_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
50ANDA040658HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2006-01-19ANDA040658_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
51ANDA040729HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040729_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
52ANDA040736HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040736_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
53ANDA040746HYDROCODONE BITARTRATE AND ACETAMINOPHENAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040746_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
54ANDA040748HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040748_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
55ANDA040754HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040754_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
56ANDA040757HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-25ANDA040757_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
57ANDA040769HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2006-08-28ANDA040769_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
58ANDA040813HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueAMNEAL PHARMACEUTICALS NY LLC2007-02-23ANDA040813_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
59ANDA040822HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueRANBAXY LABORATORIES LTD2007-08-16ANDA040822_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
60ANDA040824HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueRANBAXY LABORATORIES INC2007-08-16ANDA040824_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
61ANDA040825HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueRANBAXY INC2007-08-16ANDA040825_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
62ANDA040826HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueSUN PHARMACEUTICAL INDUSTRIES LTD2007-08-16ANDA040826_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
63ANDA040846HYDROCODONE BITARTRATE AND ACETAMINOPHENMIKART INC2010-06-09ANDA040846_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
64ANDA040849HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC2010-06-09ANDA040849_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
65ANDA081079HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1991-08-30ANDA081079_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
66ANDA081080HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1991-08-30ANDA081080_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
67ANDA081083HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1991-08-30ANDA081083_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
68ANDA081223HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1992-05-29ANDA081223_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
69ANDA085057TYLENOL W/ CODEINETrueORTHO MCNEIL PHARMACEUTICAL INCANDA085057_001
70ANDA085667VICODINTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA085667_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
71ANDA085861ACETAMINOPHEN AND CODEINE PHOSPHATETrueACTAVIS MID ATLANTIC LLCANDA085861_001
72ANDA086366ACETAMINOPHEN AND CODEINE PHOSPHATETrueROXANE LABORATORIES INCANDA086366_001
73ANDA087006ACETAMINOPHEN AND CODEINE PHOSPHATEWOCKHARDT EU OPERATIONS (SWISS) AGANDA087006_001
74ANDA087508ACETAMINOPHEN AND CODEINE PHOSPHATEPHARMACEUTICAL ASSOCIATES INCANDA087508_001
75ANDA087677HY-PHENTrueBF ASCHER AND CO INC1982-05-03ANDA087677_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
76ANDA087722LORTABTrueUCB INC1982-07-09ANDA087722_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
77ANDA087757CO-GESICTrueUCB INC1982-05-03ANDA087757_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
78ANDA087809DURADYNE DHCTrueFOREST PHARMACEUTICALS INC1983-03-17ANDA087809_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
79ANDA088058VICODINTrueABBVIE INC1983-01-07ANDA088058_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
80ANDA088577HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueBARR LABORATORIES INC1984-12-21ANDA088577_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
81ANDA088871NORCETTrueABANA PHARMACEUTICALS INC1986-05-15ANDA088871_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
82ANDA089160ANEXSIATrueMALLINCKRODT CHEMICAL INC1987-04-23ANDA089160_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
83ANDA089271HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1986-07-16ANDA089271_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
84ANDA089290HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUSL PHARMA INC1987-05-29ANDA089290_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
85ANDA089291HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueUSL PHARMA INC1987-05-29ANDA089291_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
86ANDA089385TYCOLETTrueORTHO MCNEIL PHARMACEUTICAL INC1986-08-27ANDA089385_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
87ANDA089450ACETAMINOPHEN AND CODEINE PHOSPHATEMIKART INC1992-10-27ANDA089450_001
88ANDA089554HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueHALSEY DRUG CO INC1987-06-12ANDA089554_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
89ANDA089689HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1988-06-29ANDA089689_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
90ANDA089696HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueIVAX PHARMACEUTICALS INC1988-04-21ANDA089696_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
91ANDA089697HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1992-01-28ANDA089697_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
92ANDA089698HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1989-08-25ANDA089698_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
93ANDA089699HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueMIKART INC1989-08-25ANDA089699_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
94ANDA089725ANEXSIA 7.5/650TrueMALLINCKRODT CHEMICAL INC1987-09-30ANDA089725_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
95ANDA089736VICODIN ESTrueABBVIE INC1988-12-09ANDA089736_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
96ANDA089831HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1988-09-07ANDA089831_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
97ANDA089883HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1988-12-01ANDA089883_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
98ANDA089971HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1988-12-02ANDA089971_001Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
99ANDA090118HYDROCODONE BITARTRATE AND ACETAMINOPHENSUN PHARMACEUTICAL INDUSTRIES INC2008-12-23ANDA090118_001, ANDA090118_002, ANDA090118_003Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
100ANDA090265HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueCARACO PHARMACEUTICAL LABORATORIES LTD2008-12-23ANDA090265_001, ANDA090265_002, ANDA090265_003Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
101ANDA090380HYDROCODONE BITARTRATE AND ACETAMINOPHENTrueCARACO PHARMACEUTICAL LABORATORIES LTD2008-12-23ANDA090380_001, ANDA090380_002, ANDA090380_003, ANDA090380_004Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
102ANDA090415HYDROCODONE BITARTRATE AND ACETAMINOPHENVINTAGE PHARMACEUTICALS2011-01-24ANDA090415_001, ANDA090415_002, ANDA090415_003Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
103ANDA091238ACETAMINOPHEN AND CODEINE PHOSPHATEVINTAGE PHARMACEUTICALS INC2011-11-10ANDA091238_001
104ANDA201013HYDROCODONE BITARTRATE AND ACETAMINOPHENAUROLIFE PHARMA LLC2012-04-11ANDA201013_001, ANDA201013_002, ANDA201013_003Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet
105ANDA202214HYDROCODONE BITARTRATE AND ACETAMINOPHENTRIS PHARMA INC2013-03-27ANDA202214_001, ANDA202214_002, ANDA202214_003Alprazolam Oral Tablet
Acetaminophen / Hydrocodone Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040084_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1995-06-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN
2ANDA040084_002discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1995-06-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN
3ANDA040084_003discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-07-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
4ANDA040084_004discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1996-10-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
5ANDA040094_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1995-09-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
6ANDA040094_002discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1995-09-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
7ANDA040094_003discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (660MG)ORALTABLETFalse2000-08-08HYDROCODONE BITARTRATE AND ACETAMINOPHEN
8ANDA040094_004discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1999-03-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
9ANDA040098_001discontinuedCODEINE PHOSPHATE (12MG/5ML), ACETAMINOPHEN (120MG/5ML)ORALSOLUTIONFalse1996-09-20ACETAMINOPHEN AND CODEINE PHOSPHATE
10ANDA040099_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETTrueAA1997-06-25NORCO
11ANDA040100_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-01-26LORTAB
12ANDA040117_001discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-09-23VICODIN HP
13ANDA040119_001RXACETAMINOPHEN (120MG/5ML), CODEINE PHOSPHATE (12MG/5ML)ORALSOLUTIONFalseAA1996-04-26ACETAMINOPHEN AND CODEINE PHOSPHATE
14ANDA040122_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
15ANDA040122_002discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
16ANDA040123_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
17ANDA040123_002discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
18ANDA040123_003discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
19ANDA040123_004discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1996-03-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN
20ANDA040134_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1996-11-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
21ANDA040143_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1996-02-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
22ANDA040144_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1996-02-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
23ANDA040144_002discontinuedHYDROCODONE BITARTRATE (2.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1997-04-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
24ANDA040148_001RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETTrueAA1997-02-14HYDROCODONE BITARTRATE AND ACETAMINOPHEN
25ANDA040148_002discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1997-02-14HYDROCODONE BITARTRATE AND ACETAMINOPHEN
26ANDA040148_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETTrueAA2000-09-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN
27ANDA040148_004RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalseAA2014-07-07HYDROCODONE BITARTRATE AND ACETAMINOPHEN
28ANDA040148_005RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2014-07-07HYDROCODONE BITARTRATE AND ACETAMINOPHEN
29ANDA040149_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1997-01-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
30ANDA040149_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1997-01-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
31ANDA040155_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1997-04-14HYDROCODONE BITARTRATE AND ACETAMINOPHEN
32ANDA040157_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1996-04-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN
33ANDA040201_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1998-02-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
34ANDA040201_002discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1998-02-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
35ANDA040210_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1997-08-13HYDROCODONE BITARTRATE AND ACETAMINOPHEN
36ANDA040236_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1997-09-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
37ANDA040236_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse1997-09-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
38ANDA040240_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1997-11-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
39ANDA040240_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1997-11-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
40ANDA040248_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalse2000-04-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
41ANDA040248_002discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2000-04-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
42ANDA040280_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
43ANDA040280_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
44ANDA040280_003discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
45ANDA040281_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
46ANDA040281_002discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1998-09-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
47ANDA040288_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (400MG)ORALTABLETFalse1998-11-27ZYDONE
48ANDA040288_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (400MG)ORALTABLETFalse1998-11-27ZYDONE
49ANDA040288_003discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (400MG)ORALTABLETFalse1998-11-27ZYDONE
50ANDA040307_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
51ANDA040307_002discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
52ANDA040307_003discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
53ANDA040307_004discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
54ANDA040308_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
55ANDA040308_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
56ANDA040309_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
57ANDA040355_001RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2000-05-31HYDROCODONE BITARTRATE AND ACETAMINOPHEN
58ANDA040356_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2000-05-31HYDROCODONE BITARTRATE AND ACETAMINOPHEN
59ANDA040358_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (660MG)ORALTABLETFalse2000-05-31HYDROCODONE BITARTRATE AND ACETAMINOPHEN
60ANDA040400_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2000-07-26HYDROCODONE BITARTRATE AND ACETAMINOPHEN
61ANDA040405_001RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2000-09-08ANEXSIA 7.5/325
62ANDA040409_001RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2000-10-20ANEXSIA 5/325
63ANDA040432_001RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2003-01-22HYDROCODONE BITARTRATE AND ACETAMINOPHEN
64ANDA040464_001discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2002-10-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
65ANDA040464_002discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2002-10-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
66ANDA040468_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2002-10-31ANEXSIA
67ANDA040469_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2002-10-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
68ANDA040473_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2002-11-06HYDROCODONE BITARTRATE AND ACETAMINOPHEN
69ANDA040474_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2003-01-02HYDROCODONE BITARTRATE AND ACETAMINOPHEN
70ANDA040476_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2002-10-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
71ANDA040477_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2002-11-06HYDROCODONE BITARTRATE AND ACETAMINOPHEN
72ANDA040478_001discontinuedACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2002-11-08HYDROCODONE BITARTRATE AND ACETAMINOPHEN
73ANDA040490_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2003-05-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
74ANDA040493_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2003-05-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
75ANDA040494_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2003-05-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
76ANDA040495_001discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2003-05-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
77ANDA040556_001RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETTrueAA2004-06-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
78ANDA040556_002RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETTrueAA2006-03-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
79ANDA040655_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2006-01-19HYDROCODONE BITARTRATE AND ACETAMINOPHEN
80ANDA040656_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAA2006-01-19HYDROCODONE BITARTRATE AND ACETAMINOPHEN
81ANDA040658_001RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETTrueAA2006-01-19HYDROCODONE BITARTRATE AND ACETAMINOPHEN
82ANDA040729_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
83ANDA040736_001RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
84ANDA040746_001RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
85ANDA040748_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
86ANDA040754_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
87ANDA040757_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2006-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
88ANDA040769_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse2006-08-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
89ANDA040813_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2007-02-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
90ANDA040822_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
91ANDA040824_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
92ANDA040825_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
93ANDA040826_001discontinuedHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (325MG)ORALTABLETFalse2007-08-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
94ANDA040846_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETTrueAA2010-06-09HYDROCODONE BITARTRATE AND ACETAMINOPHEN
95ANDA040849_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2010-06-09HYDROCODONE BITARTRATE AND ACETAMINOPHEN
96ANDA081079_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (2.5MG)ORALTABLETFalse1991-08-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
97ANDA081080_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1991-08-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
98ANDA081083_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1991-08-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN
99ANDA081223_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse1992-05-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
100ANDA085057_001discontinuedACETAMINOPHEN (120MG/5ML), CODEINE PHOSPHATE (12MG/5ML)ORALSOLUTIONFalseTYLENOL W/ CODEINE
101ANDA085667_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalseVICODIN
102ANDA085861_001discontinuedCODEINE PHOSPHATE (12MG/5ML), ACETAMINOPHEN (120MG/5ML)ORALSOLUTIONFalseACETAMINOPHEN AND CODEINE PHOSPHATE
103ANDA086366_001discontinuedCODEINE PHOSPHATE (12MG/5ML), ACETAMINOPHEN (120MG/5ML)ORALSOLUTIONFalseACETAMINOPHEN AND CODEINE PHOSPHATE
104ANDA087006_001RXACETAMINOPHEN (120MG/5ML), CODEINE PHOSPHATE (12MG/5ML)ORALSOLUTIONFalseAAACETAMINOPHEN AND CODEINE PHOSPHATE
105ANDA087508_001RXACETAMINOPHEN (120MG/5ML), CODEINE PHOSPHATE (12MG/5ML)ORALSOLUTIONTrueAAACETAMINOPHEN AND CODEINE PHOSPHATE
106ANDA087677_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1982-05-03HY-PHEN
107ANDA087722_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1982-07-09LORTAB
108ANDA087757_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1982-05-03CO-GESIC
109ANDA087809_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1983-03-17DURADYNE DHC
110ANDA088058_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1983-01-07VICODIN
111ANDA088577_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1984-12-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
112ANDA088871_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1986-05-15NORCET
113ANDA089160_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1987-04-23ANEXSIA
114ANDA089271_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1986-07-16HYDROCODONE BITARTRATE AND ACETAMINOPHEN
115ANDA089290_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1987-05-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
116ANDA089291_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1987-05-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
117ANDA089385_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1986-08-27TYCOLET
118ANDA089450_001RXCODEINE PHOSPHATE (12MG/5ML), ACETAMINOPHEN (120MG/5ML)ORALSOLUTIONFalseAA1992-10-27ACETAMINOPHEN AND CODEINE PHOSPHATE
119ANDA089554_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1987-06-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN
120ANDA089689_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1988-06-29HYDROCODONE BITARTRATE AND ACETAMINOPHEN
121ANDA089696_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1988-04-21HYDROCODONE BITARTRATE AND ACETAMINOPHEN
122ANDA089697_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1992-01-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN
123ANDA089698_001discontinuedHYDROCODONE BITARTRATE (2.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1989-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
124ANDA089699_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1989-08-25HYDROCODONE BITARTRATE AND ACETAMINOPHEN
125ANDA089725_001discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1987-09-30ANEXSIA 7.5/650
126ANDA089736_001discontinuedACETAMINOPHEN (750MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalse1988-12-09VICODIN ES
127ANDA089831_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1988-09-07HYDROCODONE BITARTRATE AND ACETAMINOPHEN
128ANDA089883_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse1988-12-01HYDROCODONE BITARTRATE AND ACETAMINOPHEN
129ANDA089971_001discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse1988-12-02HYDROCODONE BITARTRATE AND ACETAMINOPHEN
130ANDA090118_001RXHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
131ANDA090118_002RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAA2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
132ANDA090118_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
133ANDA090265_001discontinuedHYDROCODONE BITARTRATE (5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
134ANDA090265_002discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
135ANDA090265_003discontinuedACETAMINOPHEN (500MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
136ANDA090380_001discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
137ANDA090380_002discontinuedACETAMINOPHEN (650MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
138ANDA090380_003discontinuedACETAMINOPHEN (660MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
139ANDA090380_004discontinuedHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (750MG)ORALTABLETFalse2008-12-23HYDROCODONE BITARTRATE AND ACETAMINOPHEN
140ANDA090415_001RXACETAMINOPHEN (300MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2011-01-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
141ANDA090415_002RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (300MG)ORALTABLETFalseAA2011-01-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
142ANDA090415_003RXHYDROCODONE BITARTRATE (10MG), ACETAMINOPHEN (300MG)ORALTABLETFalseAA2011-01-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN
143ANDA091238_001RXACETAMINOPHEN (120MG/5ML), CODEINE PHOSPHATE (12MG/5ML)ORALSOLUTIONFalseAA2011-11-10ACETAMINOPHEN AND CODEINE PHOSPHATE
144ANDA201013_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2012-04-11HYDROCODONE BITARTRATE AND ACETAMINOPHEN
145ANDA201013_002RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (7.5MG)ORALTABLETFalseAA2012-04-11HYDROCODONE BITARTRATE AND ACETAMINOPHEN
146ANDA201013_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2012-04-11HYDROCODONE BITARTRATE AND ACETAMINOPHEN
147ANDA202214_001RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2013-03-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
148ANDA202214_002RXHYDROCODONE BITARTRATE (7.5MG), ACETAMINOPHEN (325MG)ORALTABLETFalseAA2013-03-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN
149ANDA202214_003RXACETAMINOPHEN (325MG), HYDROCODONE BITARTRATE (10MG)ORALTABLETFalseAA2013-03-27HYDROCODONE BITARTRATE AND ACETAMINOPHEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10995dd90-e20c-4733-a4ec-5eed257d62e5 (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-141500900216
22abec441-3eac-4c0e-a05a-369a1ef0e51f (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-221551549442
32f92c67b-f324-4c4e-89fd-1e0f8af96fba (view SPL)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-08-311216950547
431cce165-fdfb-434c-83c2-fcc7709c03f4 (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-141500900215
54f5ca56d-807c-4111-8267-cc9035e1a031 (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-04-271545691001
659c33fd9-ef24-4893-b904-3e5f8cea58c7 (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-11-123332610470
76f6dc6c1-8f0d-4ca3-a0df-ab9103f73f6d (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-10-121545698336
87bca1d24-a317-44c4-8db2-68030eb961ed (view SPL)prescriptionHuman PrescriptionMikart, Inc.2013-11-264466720561
97ed43443-45fc-4e72-b3be-6503b4c1c637 (view SPL)ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USPprescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-06-101672960651
1083a536d8-385d-46ed-9cd2-47b7efe96ccf (view SPL)Acetaminophen and Codeine Phosphate Oral Solution, USP120 mg/12 mg per 5 mLprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2015-03-1615503830079
1195ac6875-6b14-4cde-8efb-80704e39b8d8 (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2011-08-043001210504
129b3f274c-e7d8-4c67-aa22-bf5aa62064cc (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2006-10-274430630139
139bf3c04c-22d8-493f-8dbd-c10613042ee5 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-11-101548680378
14aa4ad524-fca4-40c7-b7e2-31772e6d4839 (view SPL)ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP 120 mg/12 mg per 5 mLprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2012-04-123178560079
15afde197c-3207-4ca5-bfa4-72099e9be419 (view SPL)Acetaminophen and Codeine Phosphate Oral Solution, USP 120 mg/12 mg per 5 mLprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-09-119687880076
16b14edc3f-4490-4ad1-ad72-185b627a033c (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870291
17b373acb5-670b-43d1-8afd-a2f8d52c015b (view SPL)Acetaminophen and Codeine Phosphate Oral Solution USP CVprescriptionHuman PrescriptionCardinal HealthREPACK2013-06-263551549415
18ccfaceb3-b3d3-4400-bae8-83e2ee272021 (view SPL)ACETAMINOPHEN & CODEINE PHOSPHATE ORAL SOLUTIONCVprescriptionHuman PrescriptionApotheca, Increpack2013-01-041126340975
19d2b39d16-03c2-4448-bcce-14d66d2069cc (view SPL)ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP 120 mg/12 mg per 5 mLprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.MANUFACTURE2013-10-284604320245
20e1da6cd0-97fb-4dc4-b754-485ff364e35f (view SPL)ACETAMINOPHENand CODEINE PHOSPHATE ORAL SOLUTION USP 120 mg/12 mg per 5 mLprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-05-0712006039013

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII