Loperamide Oral Solution

Brand(s)
Rx-Act Anti-Diarrheal
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
L. Perrigo Company (2014-08-25)
Oldest Current Product
1992-03-30
License(s)
ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
ORAL SOLUTION\LOPERAMIDE
FDAOB
ORAL\SOLUTION\LOPERAMIDE HYDROCHLORIDE
ORAL\SUSPENSION\LOPERAMIDE HYDROCHLORIDE
SPL Active
ORAL\LIQUID\LOPERAMIDE HYDROCHLORIDE
ORAL\SOLUTION\LOPERAMIDE HYDROCHLORIDE
SPL Moiety
ORAL\LIQUID\LOPERAMIDE
ORAL\SOLUTION\LOPERAMIDE

product(s) by strength(s)

loperamide hydrochloride 0.2 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1531130657UNAPPROVED DRUG OTHER MARKETING CATEGORYGadal Laboratories Inc2013-05-01LOPERAMIDE HYDROCHLORIDEORALLIQUIDfa02a809-167c-4978-8226-6b42479b91e0

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130377ANDAL. Perrigo Company1992-03-30LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA0732433cb25c6f-fee6-461f-8f8f-56d9123faec3
2116730377ANDATarget Corp2009-07-31LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA0732433a759463-f622-4f15-a34f-0bf8e3af7942
3118220377ANDARite Aid1992-07-13LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA07324340204b82-b7c6-447a-89b0-3571bfa83ff7
4243850377ANDAGood Neighbor Pharmacy2003-09-19LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA073243e6f5d456-c674-4b93-80b4-2a57e23bf8ed
5372050377ANDACardinal Health1997-10-28LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA0732439b7fdde3-34a0-4a44-95db-1f5d3bc51d27
6378080377Rx-Act Anti-DiarrhealANDAH-E-B1992-05-14LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA073243b2168682-c019-4b7f-83a9-42e995b28ded
7412500377ANDAMeijer Distribution, Inc1992-04-17LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA073243f22bd36f-bf30-4ecd-a12b-089a14070f16
8493480277ANDASunmark2003-09-19LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA073243b5132a26-dc9f-4495-97fa-9225b87e1c8a
9497380377ANDAKmart Corp2011-02-03LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA07324346303345-ce31-4d6c-9363-e611fa81ec19
10503830618ANDAHi-Tech Pharmacal Co., Inc.1995-11-17LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA0743523a624112-2903-43fb-9c6b-a9a4fc03da9c
11559100377ANDADolgencorp, Llc2010-08-09LOPERAMIDE HYDROCHLORIDEORALSOLUTIONANDA07324393c7ccf0-ad2c-45b1-b7b6-07d58712970c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560618ANDAAtlantic Biologicals Corps1995-11-17LOPERAMIDE HYDROCHLORIDEORALSOLUTION503830618ANDA074352b0596b9c-326d-4795-b0a5-38c858af7a77
2216950978ANDARebel Distributors Corp1992-07-13LOPERAMIDE HYDROCHLORIDEORALSOLUTION001130377ANDA0732434339d964-1997-4c0e-973e-aa69b123b33d
3551544944ANDACardinal Health1992-04-30LOPERAMIDE HYDROCHLORIDEORALSOLUTION000548535ANDA0730796009ceb6-032d-45af-95b6-de969a196bcf
4680940106ANDAPrecision Dose Inc.2009-09-01LOPERAMIDE HYDROCHLORIDEORALSOLUTION001130377ANDA0732437e51dc28-4f25-4558-af7c-46d4806e137b
5680940217ANDAPrecision Dose Inc.2009-08-18LOPERAMIDE HYDROCHLORIDEORALSOLUTION001130377ANDA0732437e51dc28-4f25-4558-af7c-46d4806e137b
6687889773ANDAPreferred Pharmaceuticals, Inc.2012-07-27LOPERAMIDE HYDROCHLORIDEORALSOLUTION503830618ANDA074352ad232149-329c-4f3d-b1c9-b34975a428fb

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA073062LOPERAMIDE HYDROCHLORIDETrueWATSON LABORATORIES INC1993-05-28ANDA073062_001Lorazepam Oral Solution
Loperamide Oral Suspension
2ANDA073079LOPERAMIDE HYDROCHLORIDEROXANE LABORATORIES INC1992-04-30ANDA073079_001Lorazepam Oral Solution
Loperamide Oral Suspension
3ANDA073187LOPERAMIDE HYDROCHLORIDETrueALPHARMA US PHARMACEUTICALS DIVISION1992-09-15ANDA073187_001Lorazepam Oral Solution
Loperamide Oral Suspension
4ANDA073243LOPERAMIDE HYDROCHLORIDEL PERRIGO CO1992-01-21ANDA073243_001Lorazepam Oral Solution
Loperamide Oral Suspension
5ANDA073478LOPERAMIDE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1995-06-23ANDA073478_001Lorazepam Oral Solution
Loperamide Oral Suspension
6ANDA074352LOPERAMIDE HYDROCHLORIDEHI TECH PHARMACAL CO INC1995-11-17ANDA074352_001Lorazepam Oral Solution
Loperamide Oral Suspension
7ANDA074730LOPERAMIDE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG1997-08-28ANDA074730_001Lorazepam Oral Solution
Loperamide Oral Suspension
8ANDA074991LOPERAMIDE HYDROCHLORIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1997-12-29ANDA074991_001Lorazepam Oral Solution
Loperamide Oral Suspension
9NDA019037IMODIUMTrueJANSSEN PHARMACEUTICALS INC1984-07-31NDA019037_001Lorazepam Oral Solution
Loperamide Oral Suspension
10NDA019487IMODIUM A-DJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1988-03-01NDA019487_001, NDA019487_002Lorazepam Oral Solution
Loperamide Oral Suspension

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA073062_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1993-05-28LOPERAMIDE HYDROCHLORIDE
2ANDA073079_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-04-30LOPERAMIDE HYDROCHLORIDE
3ANDA073187_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-09-15LOPERAMIDE HYDROCHLORIDE
4ANDA073243_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1992-01-21LOPERAMIDE HYDROCHLORIDE
5ANDA073478_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1995-06-23LOPERAMIDE HYDROCHLORIDE
6ANDA074352_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1995-11-17LOPERAMIDE HYDROCHLORIDE
7ANDA074730_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1997-08-28LOPERAMIDE HYDROCHLORIDE
8ANDA074991_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1997-12-29LOPERAMIDE HYDROCHLORIDE
9NDA019037_001discontinuedLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONFalse1984-07-31IMODIUM
10NDA019487_001OTCLOPERAMIDE HYDROCHLORIDE (1MG/5ML)ORALSOLUTIONTrue1988-03-01IMODIUM A-D
11NDA019487_002OTCLOPERAMIDE HYDROCHLORIDE (1MG/7.5ML)ORALSUSPENSIONTrue2004-07-08IMODIUM A-D

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13a624112-2903-43fb-9c6b-a9a4fc03da9c (view SPL)Drug FactsotcHuman OTCHi-Tech Pharmacal Co., Inc.2013-07-183503830618
23a759463-f622-4f15-a34f-0bf8e3af7942 (view SPL)Target Corp. Anti-Diarrheal Drug FactsotcHuman OTCTarget Corp2009-07-311116730377
33cb25c6f-fee6-461f-8f8f-56d9123faec3 (view SPL)Perrigo Anti-Diarrheal Drug FactsotcHuman OTCL. Perrigo Company2014-08-251001130377
440204b82-b7c6-447a-89b0-3571bfa83ff7 (view SPL)Rite Aid Corporation Anti-Diarrheal Drug FactsotcHuman OTCRite Aid2009-06-021118220377
54339d964-1997-4c0e-973e-aa69b123b33d (view SPL)Rite Aid Corporation Anti-Diarrheal Drug FactsotcHuman OTCRebel Distributors CorpRELABEL, REPACK2011-09-131216950978
646303345-ce31-4d6c-9363-e611fa81ec19 (view SPL)Kmart Corporation Anti-Diarrheal Drug FactsotcHuman OTCKmart Corp2009-06-021497380377
76009ceb6-032d-45af-95b6-de969a196bcf (view SPL)LOPERAMIDE HYDROCHLORIDE ORAL SOLUTION1 mg per 5 mLprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-221551544944
87e51dc28-4f25-4558-af7c-46d4806e137b (view SPL)LOPERAMIDE HYDROCHLORIDE ORAL SOLUTIONotcHuman OTCPrecision Dose Inc.2012-02-172680940106, 680940217
993c7ccf0-ad2c-45b1-b7b6-07d58712970c (view SPL)Dolgencorp, LLC Anti-Diarrheal Drug FactsotcHuman OTCDolgencorp, Llc2011-11-041559100377
109b7fdde3-34a0-4a44-95db-1f5d3bc51d27 (view SPL)Cardinal Health Anti-Diarrheal Drug FactsotcHuman OTCCardinal Health2012-02-221372050377
11ad232149-329c-4f3d-b1c9-b34975a428fb (view SPL)Drug FactsotcHuman OTCPreferred Pharmaceuticals, Inc.RELABEL2015-01-282687889773
12b0596b9c-326d-4795-b0a5-38c858af7a77 (view SPL)Drug FactsotcHuman OTCAtlantic Biologicals CorpsRELABEL, REPACK2013-07-184178560618
13b2168682-c019-4b7f-83a9-42e995b28ded (view SPL)HEB Anti-Diarrheal Drug FactsotcHuman OTCH-E-B2009-06-021378080377
14b5132a26-dc9f-4495-97fa-9225b87e1c8a (view SPL)McKesson Anti-Diarrheal Drug FactsotcHuman OTCSunmark2009-06-021493480277
15e6f5d456-c674-4b93-80b4-2a57e23bf8ed (view SPL)Amerisource Bergen Anti-Diarrheal Drug FactsotcHuman OTCGood Neighbor Pharmacy2009-06-021243850377
16f22bd36f-bf30-4ecd-a12b-089a14070f16 (view SPL)Meijer Distribution, Inc. Anti-Diarrheal Liquid Drug FactsotcHuman OTCMeijer Distribution, Inc2012-03-131412500377
17fa02a809-167c-4978-8226-6b42479b91e0 (view SPL)Drug FactsotcHuman OTCGadal Laboratories Inc2013-05-221531130657

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