Cimetidine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Morton Grove Pharmaceuticals, Inc. (2014-02-03)
Oldest Current Product
1997-03-12
License(s)
ANDA
RxNORM
ORAL SOLUTION\CIMETIDINE
FDAOB
ORAL\SOLUTION\CIMETIDINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\CIMETIDINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\CIMETIDINE

product(s) by strength(s)

cimetidine 60 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1604320007ANDAMorton Grove Pharmaceuticals, Inc.1997-03-12CIMETIDINE HYDROCHLORIDEORALSOLUTIONANDA074757d7b4d497-0b70-49e8-b17b-643fa82a0d8c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1503830050ANDAHi-Tech Pharmacal Co., Inc.1997-10-28CIMETIDINE HYDROCHLORIDEORALSOLUTION503830050ANDA074664f2ec923a-2b88-43c0-ac2a-7ae20c053039

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074176CIMETIDINE HYDROCHLORIDETrueG AND W LABORATORIES INC1994-06-01ANDA074176_001
2ANDA074251CIMETIDINE HYDROCHLORIDETrueVINTAGE PHARMACEUTICALS LLC1994-12-22ANDA074251_001
3ANDA074541CIMETIDINE HYDROCHLORIDETrueCYCLE PHARMACEUTICALS LTD1997-08-05ANDA074541_001
4ANDA074553CIMETIDINE HYDROCHLORIDEPHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS1997-01-27ANDA074553_001
5ANDA074610CIMETIDINE HYDROCHLORIDEANI PHARMACEUTICALS INC1996-09-26ANDA074610_001
6ANDA074664CIMETIDINE HYDROCHLORIDEHI TECH PHARMACAL CO INC1997-10-28ANDA074664_001
7ANDA074757CIMETIDINE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG1997-10-17ANDA074757_001
8ANDA074859CIMETIDINE HYDROCHLORIDETrueANI PHARMACEUTICALS INC1998-07-09ANDA074859_001
9ANDA075110CIMETIDINE HYDROCHLORIDETrueANI PHARMACEUTICALS INC1998-06-18ANDA075110_001
10ANDA075560CIMETIDINE HYDROCHLORIDETrueAPOTEX INC2000-03-15ANDA075560_001
11NDA017924TAGAMETTrueGLAXOSMITHKLINENDA017924_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074176_001discontinuedCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalse1994-06-01CIMETIDINE HYDROCHLORIDE
2ANDA074251_001discontinuedCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalse1994-12-22CIMETIDINE HYDROCHLORIDE
3ANDA074541_001discontinuedCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalse1997-08-05CIMETIDINE HYDROCHLORIDE
4ANDA074553_001RXCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalseAA1997-01-27CIMETIDINE HYDROCHLORIDE
5ANDA074610_001RXCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalseAA1996-09-26CIMETIDINE HYDROCHLORIDE
6ANDA074664_001RXCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONTrueAA1997-10-28CIMETIDINE HYDROCHLORIDE
7ANDA074757_001RXCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalseAA1997-10-17CIMETIDINE HYDROCHLORIDE
8ANDA074859_001discontinuedCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalse1998-07-09CIMETIDINE HYDROCHLORIDE
9ANDA075110_001discontinuedCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalse1998-06-18CIMETIDINE HYDROCHLORIDE
10ANDA075560_001discontinuedCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalse2000-03-15CIMETIDINE HYDROCHLORIDE
11NDA017924_001discontinuedCIMETIDINE HYDROCHLORIDE (EQ 300MG BASE/5ML)ORALSOLUTIONFalseTAGAMET

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1d7b4d497-0b70-49e8-b17b-643fa82a0d8c (view SPL)CIMETIDINE HYDROCHLORIDE ORAL SOLUTIONprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-02-034604320007
2f2ec923a-2b88-43c0-ac2a-7ae20c053039 (view SPL)Cimetidine Hydrochloride Oral SolutionprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2009-08-271503830050

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