Cephalexin Oral Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-07-20)
Oldest Current Product
1990-09-30
License(s)
ANDA
RxNORM
ORAL SUSPENSION\CEPHALEXIN
FDAOB
ORAL\FOR SUSPENSION\CEPHALEXIN
SPL Active
ORAL\FOR SUSPENSION\CEPHALEXIN
ORAL\POWDER, FOR SUSPENSION\CEPHALEXIN
ORAL\SUSPENSION\CEPHALEXIN
ORAL\SUSPENSION\CEPHALEXIN ANHYDROUS
SPL Moiety
ORAL\FOR SUSPENSION\CEPHALEXIN ANHYDROUS
ORAL\POWDER, FOR SUSPENSION\CEPHALEXIN
ORAL\POWDER, FOR SUSPENSION\CEPHALEXIN ANHYDROUS
ORAL\SUSPENSION\CEPHALEXIN
ORAL\SUSPENSION\CEPHALEXIN ANHYDROUS

product(s) by strength(s)

cephalexin 25 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934175ANDATeva Pharmaceuticals Usa Inc1990-09-30CEPHALEXINORALPOWDER, FOR SUSPENSIONANDA06270319307ff0-71de-477b-965d-ea243e5ede3a
2420430142ANDAOrchidpharma Inc2007-04-12CEPHALEXINORALPOWDER, FOR SUSPENSIONANDA065326561d93f2-0282-4dec-bac9-840923657df7
3598340202ANDAOrchidpharma Inc2011-09-01CEPHALEXINORALPOWDER, FOR SUSPENSIONANDA065326cb31cd1b-100d-4a24-b314-1ddcd6a95314
4681800123ANDALupin Pharmaceuticals, Inc.2006-01-11CEPHALEXINORALFOR SUSPENSIONANDA06523425ef498a-7a7e-4543-a544-b9d0e99f9cd9

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001439769ANDAWest-Ward Pharmaceutical Corp2009-09-01CEPHALEXINORALSUSPENSIONANDA0654441fc40f29-1d19-4ee3-97d3-f9dddf27f2ae
2548680538ANDAPhysicians Total Care, Inc.1994-12-09CEPHALEXINORALSUSPENSION633040958ANDA065081d9a049bd-2161-4a9b-8f6d-0c7d2bfdb0ed
3614420201ANDACarlsbad Technology, Inc.2009-06-01CEPHALEXINORALSUSPENSIONANDA06533622ab5dba-bfce-498d-a644-9ca0e343b1cf
4682890008ANDAJazeera Pharmaceutical2009-09-01CEPHALEXIN ANHYDROUSORALSUSPENSIONANDA0654442b388b1e-cd59-42de-ba72-858485b070b7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900466ANDAStat Rx Usa Llc2007-12-07CEPHALEXINORALPOWDER, FOR SUSPENSION420430142ANDA065326b5da860d-9cfc-4020-bc81-11f2a01e660b
2216950789ANDARebel Distributors Corp2010-09-21CEPHALEXINORALPOWDER, FOR SUSPENSION000934175ANDA0627034e334e50-19c4-449b-b77f-549a461c7f84
3422540338ANDARebel Distributors Corp2007-12-07CEPHALEXINORALPOWDER, FOR SUSPENSION420430142ANDA065326a00e07e9-2c16-4d3e-bb63-6fd2b05fe1b7
4545691023ANDAA-S Medication Solutions Llc1990-09-30CEPHALEXINORALPOWDER, FOR SUSPENSION000934175ANDA062703c408de52-a15e-49ec-8bcd-eede240e5225
5687889538ANDAPreferred Pharmaceuticals, Inc.2013-12-03CEPHALEXINORALPOWDER, FOR SUSPENSION000934175ANDA06270307631a8b-eb84-46aa-844e-e93e548cb9b2
6687889956ANDAPreferred Pharmaceuticals, Inc.2012-01-10CEPHALEXINORALFOR SUSPENSION681800123ANDA0652345dfec608-4a61-45d6-b535-42c4cb8a170c

cephalexin 50 mg/ml oral suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934177ANDATeva Pharmaceuticals Usa Inc1990-09-30CEPHALEXINORALPOWDER, FOR SUSPENSIONANDA06270319307ff0-71de-477b-965d-ea243e5ede3a
2420430143ANDAOrchidpharma Inc2007-04-12CEPHALEXINORALPOWDER, FOR SUSPENSIONANDA065326561d93f2-0282-4dec-bac9-840923657df7
3598340203ANDAOrchidpharma Inc2011-09-01CEPHALEXINORALPOWDER, FOR SUSPENSIONANDA065326cb31cd1b-100d-4a24-b314-1ddcd6a95314

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001439770ANDAWest-Ward Pharmaceutical Corp2009-09-01CEPHALEXINORALSUSPENSIONANDA0654441fc40f29-1d19-4ee3-97d3-f9dddf27f2ae
2548681385ANDAPhysicians Total Care, Inc.1993-06-22CEPHALEXINORALSUSPENSION633040959ANDA065081d9a049bd-2161-4a9b-8f6d-0c7d2bfdb0ed
3614420202ANDACarlsbad Technology, Inc.2009-06-01CEPHALEXINORALSUSPENSIONANDA06533622ab5dba-bfce-498d-a644-9ca0e343b1cf
4682890009ANDAJazeera Pharmaceutical2009-09-01CEPHALEXIN ANHYDROUSORALSUSPENSIONANDA0654442b388b1e-cd59-42de-ba72-858485b070b7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900049ANDAStat Rx Usa Llc2007-12-04CEPHALEXINORALPOWDER, FOR SUSPENSION420430143ANDA065326b5da860d-9cfc-4020-bc81-11f2a01e660b
2216950551ANDARebel Distributors Corp2010-09-21CEPHALEXINORALPOWDER, FOR SUSPENSION000934177ANDA0627034e334e50-19c4-449b-b77f-549a461c7f84
3332610485ANDAAidarex Pharmaceuticals Llc2006-01-11CEPHALEXINORALFOR SUSPENSION681800124ANDA065234fc538c6b-ddaf-4e09-ae8b-998e3065fa71
4529590620ANDAH.J. Harkins Company, Inc.2005-08-01CEPHALEXINORALFOR SUSPENSION681800124ANDA0652349a75fb7c-c249-4885-8a8f-78678b537452
5545691024ANDAA-S Medication Solutions Llc1990-09-30CEPHALEXINORALPOWDER, FOR SUSPENSION000934177ANDA062703c408de52-a15e-49ec-8bcd-eede240e5225
6545691025ANDAA-S Medication Solutions Llc1990-09-30CEPHALEXINORALPOWDER, FOR SUSPENSION000934177ANDA062703237505d8-59c1-456e-a28c-c66769dad0d9
7617860476ANDARemedyrepack Inc.2015-11-12CEPHALEXINORALPOWDER, FOR SUSPENSION000934177ANDA062703a0be9e7a-aeff-4e44-a241-8d3dc558dfd7
8619190049ANDADirect Rx2014-01-01CEPHALEXINORALSUSPENSION681800124ANDA0652342b9516da-d99b-4d12-b45b-01c03576f3f0
9631870205ANDAProficient Rx Lp1990-09-30CEPHALEXINORALPOWDER, FOR SUSPENSION000934177ANDA062703febab51b-6b48-488a-8fd1-d24400e5df1d
10661160607ANDAMedvantx, Inc.1990-09-30CEPHALEXINORALPOWDER, FOR SUSPENSION000934177ANDA062703ca2ed054-b1a5-4174-b107-a26d8c9b31b2
11687889539ANDAPreferred Pharmaceuticals, Inc.2013-12-03CEPHALEXINORALPOWDER, FOR SUSPENSION000934177ANDA06270307631a8b-eb84-46aa-844e-e93e548cb9b2
12687889957ANDAPreferred Pharmaceuticals, Inc.2012-01-10CEPHALEXINORALFOR SUSPENSION681800124ANDA0652345dfec608-4a61-45d6-b535-42c4cb8a170c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062117CEPHALEXINTrueFACTA FARMACEUTICI SPAANDA062117_001, ANDA062117_002, ANDA062117_003
2ANDA062703CEPHALEXINTEVA PHARMACEUTICALS USA INC1987-02-13ANDA062703_001, ANDA062703_002
3ANDA062767CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1987-06-16ANDA062767_001
4ANDA062768CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1987-06-16ANDA062768_001
5ANDA062777CEPHALEXINTrueBARR LABORATORIES INC1987-08-06ANDA062777_001
6ANDA062778CEPHALEXINTrueBARR LABORATORIES INC1987-08-06ANDA062778_001
7ANDA062779CEPHALEXINTrueVITARINE PHARMACEUTICALS INC1987-12-22ANDA062779_001
8ANDA062781CEPHALEXINTrueVITARINE PHARMACEUTICALS INC1987-12-22ANDA062781_001
9ANDA062867CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1988-04-15ANDA062867_001
10ANDA062873CEPHALEXINTrueTEVA PHARMACEUTICALS USA INC1988-05-23ANDA062873_001
11ANDA062986CEPHALEXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1991-04-18ANDA062986_001
12ANDA062987CEPHALEXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1989-07-25ANDA062987_001
13ANDA065081CEPHALEXINTrueSUN PHARMACEUTICAL INDUSTRIES LTD2001-07-27ANDA065081_001, ANDA065081_002
14ANDA065234CEPHALEXINLUPIN LTD2005-08-17ANDA065234_001, ANDA065234_002
15ANDA065326CEPHALEXINORCHID HEALTHCARE2006-07-10ANDA065326_001, ANDA065326_002
16ANDA065336CEPHALEXINTrueYUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD2007-07-25ANDA065336_001, ANDA065336_002
17ANDA065444CEPHALEXINTrueHIKMA PHARMACEUTICALS2009-08-28ANDA065444_001, ANDA065444_002
18NDA050406KEFLEXTrueSHIONOGI INCNDA050406_001, NDA050406_002, NDA050406_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062117_001discontinuedCEPHALEXIN (EQ 100MG BASE/ML)ORALFOR SUSPENSIONFalseCEPHALEXIN
2ANDA062117_002discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseCEPHALEXIN
3ANDA062117_003discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseCEPHALEXIN
4ANDA062703_001RXCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAB1987-02-13CEPHALEXIN
5ANDA062703_002RXCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONTrueAB1987-02-13CEPHALEXIN
6ANDA062767_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1987-06-16CEPHALEXIN
7ANDA062768_001discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1987-06-16CEPHALEXIN
8ANDA062777_001discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1987-08-06CEPHALEXIN
9ANDA062778_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1987-08-06CEPHALEXIN
10ANDA062779_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1987-12-22CEPHALEXIN
11ANDA062781_001discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1987-12-22CEPHALEXIN
12ANDA062867_001discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1988-04-15CEPHALEXIN
13ANDA062873_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1988-05-23CEPHALEXIN
14ANDA062986_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse1991-04-18CEPHALEXIN
15ANDA062987_001discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse1989-07-25CEPHALEXIN
16ANDA065081_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse2001-07-27CEPHALEXIN
17ANDA065081_002discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse2001-07-27CEPHALEXIN
18ANDA065234_001RXCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2005-08-17CEPHALEXIN
19ANDA065234_002RXCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2005-08-17CEPHALEXIN
20ANDA065326_001RXCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2006-07-10CEPHALEXIN
21ANDA065326_002RXCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseAB2006-07-10CEPHALEXIN
22ANDA065336_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse2007-07-25CEPHALEXIN
23ANDA065336_002discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse2007-07-25CEPHALEXIN
24ANDA065444_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalse2009-08-28CEPHALEXIN
25ANDA065444_002discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalse2009-08-28CEPHALEXIN
26NDA050406_001discontinuedCEPHALEXIN (EQ 125MG BASE/5ML)ORALFOR SUSPENSIONFalseKEFLEX
27NDA050406_002discontinuedCEPHALEXIN (EQ 250MG BASE/5ML)ORALFOR SUSPENSIONFalseKEFLEX
28NDA050406_003discontinuedCEPHALEXIN (EQ 100MG BASE/ML)ORALFOR SUSPENSIONFalseKEFLEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
107631a8b-eb84-46aa-844e-e93e548cb9b2 (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-12-261687889538, 687889539
219307ff0-71de-477b-965d-ea243e5ede3a (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg314531474175417722382240Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-07-2013000934175, 000934177, 000932238, 000932240, 000933145, 000933147Cephalexin Oral Capsule
Cephalexin Oral Tablet
31fc40f29-1d19-4ee3-97d3-f9dddf27f2ae (view SPL)Cephalexin for Oral Suspension USPRx Only Rev. 09/09prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2011-08-025001439769, 001439770
422ab5dba-bfce-498d-a644-9ca0e343b1cf (view SPL)CEPHALEXIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionCarlsbad Technology, Inc.MANUFACTURE2010-10-043614420201, 614420202
5237505d8-59c1-456e-a28c-c66769dad0d9 (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg314531474175417722382240Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545691025
625ef498a-7a7e-4543-a544-b9d0e99f9cd9 (view SPL)CEPHALEXIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2012-09-122681800123
72b388b1e-cd59-42de-ba72-858485b070b7 (view SPL)Cephalexin for Oral Suspension USPprescriptionHuman PrescriptionJazeera Pharmaceutical2009-09-112682890008, 682890009
82b9516da-d99b-4d12-b45b-01c03576f3f0 (view SPL)CEPHALEXINprescriptionHuman PrescriptionDirect Rxrelabel2014-12-151619190049
94e334e50-19c4-449b-b77f-549a461c7f84 (view SPL)CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950551, 216950789
10561d93f2-0282-4dec-bac9-840923657df7 (view SPL)CEPHALEXIN FOR ORAL SUSPENSION, USPRx onlyprescriptionHuman PrescriptionOrchidpharma Incanalysis, label, manufacture, pack2014-08-189420430142, 420430143
115dfec608-4a61-45d6-b535-42c4cb8a170c (view SPL)CEPHALEXIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-08-063687889956, 687889957
129a75fb7c-c249-4885-8a8f-78678b537452 (view SPL)CEPHALEXIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-11-011529590620
13a00e07e9-2c16-4d3e-bb63-6fd2b05fe1b7 (view SPL)CEPHALEXIN FOR ORAL SUSPENSION, USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-10-301422540338
14a0be9e7a-aeff-4e44-a241-8d3dc558dfd7 (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg314531474175417722382240Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-11-121617860476
15b5da860d-9cfc-4020-bc81-11f2a01e660b (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-05-232165900049, 165900466
16c408de52-a15e-49ec-8bcd-eede240e5225 (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg314531474175417722382240Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545691023, 545691024
17ca2ed054-b1a5-4174-b107-a26d8c9b31b2 (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx onlyprescriptionHuman PrescriptionMedvantx, Inc.REPACK2012-07-251661160607
18cb31cd1b-100d-4a24-b314-1ddcd6a95314 (view SPL)CEPHALEXIN FOR ORAL SUSPENSION, USPRx onlyprescriptionHuman PrescriptionOrchidpharma Incanalysis, label, manufacture, pack2012-08-302598340202, 598340203
19d9a049bd-2161-4a9b-8f6d-0c7d2bfdb0ed (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-03-101548680538, 548681385
20fc538c6b-ddaf-4e09-ae8b-998e3065fa71 (view SPL)CEPHALEXIN FOR ORAL SUSPENSION USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-10-121332610485
21febab51b-6b48-488a-8fd1-d24400e5df1d (view SPL)CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-012631870205

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