Metoclopramide Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Morton Grove Pharmaceuticals, Inc. (2014-03-21)
Oldest Current Product
1991-06-01
License(s)
ANDA
RxNORM
ORAL SOLUTION\METOCLOPRAMIDE
FDAOB
ORAL\SOLUTION\METOCLOPRAMIDE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\METOCLOPRAMIDE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\METOCLOPRAMIDE

product(s) by strength(s)

metoclopramide 1 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001210576ANDAPharmaceutical Associates, Inc.1991-06-01METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTIONANDA0727443cc8ca5b-8b71-4c77-a181-9ce154597b9a
2001211576ANDAPharmaceutical Associates, Inc.1991-06-01METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTIONANDA0727443cc8ca5b-8b71-4c77-a181-9ce154597b9a
3604320622ANDAMorton Grove Pharmaceuticals, Inc.1997-10-31METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTIONANDA074703a637c1ac-78d1-4d44-9c79-b6da9a8f2fb9
4625590110ANDAAnip Acquisition Company2011-03-10METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTIONANDA0714026cef9808-d867-4908-964b-c57ce500dccc
5625590190ANDAAnip Acquisition Company2015-05-18METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTIONANDA0714024e12e98a-06fe-4b3c-bb64-f2701e195c74
6666890031ANDAVistapharm Inc.2010-02-12METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTIONANDA07505159abd52d-8172-44a3-baa2-fe1fe20f78c0

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1504360576ANDAUnit Dose Services1991-06-01METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTION001210576ANDA072744cf6a64e0-98ac-46a6-8d2a-1dd963cc65c5
2551549427ANDACardinal Health1991-06-01METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTION001211576ANDA0727447e727a97-3b40-46b9-af65-9bc5c220fe3e
3680940676ANDAPrecision Dose Inc.2007-11-26METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTION604320622ANDA074703baacecf3-b371-42c6-bf58-bd4141ddb665
4680940680ANDAPrecision Dose Inc.2009-06-012012-08-31METOCLOPRAMIDE HYDROCHLORIDEORALSOLUTION604320622ANDA074703baacecf3-b371-42c6-bf58-bd4141ddb665

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070819METOCLOPRAMIDE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1987-07-10ANDA070819_001
2ANDA070949METOCLOPRAMIDE HYDROCHLORIDETrueMORTON GROVE PHARMACEUTICALS INC1987-03-06ANDA070949_001
3ANDA071315METOCLOPRAMIDE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1993-06-30ANDA071315_001
4ANDA071340METOCLOPRAMIDE HYDROCHLORIDETrueACTAVIS MID ATLANTIC LLC1988-08-18ANDA071340_001
5ANDA071402METOCLOPRAMIDE HYDROCHLORIDEANI PHARMACEUTICALS INC1993-06-25ANDA071402_001
6ANDA071665METOCLOPRAMIDE HYDROCHLORIDETruePACO RESEARCH CORP1988-12-05ANDA071665_001
7ANDA072038METOCLOPRAMIDE HYDROCHLORIDETrueROXANE LABORATORIES INC1988-12-05ANDA072038_001
8ANDA072744METOCLOPRAMIDE HYDROCHLORIDEPHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS1991-05-28ANDA072744_001
9ANDA073680METOCLOPRAMIDE HYDROCHLORIDESILARX PHARMACEUTICALS INC1992-10-27ANDA073680_001
10ANDA074703METOCLOPRAMIDE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG1997-10-31ANDA074703_001
11ANDA075051METOCLOPRAMIDE HYDROCHLORIDEVISTAPHARM INC2001-01-26ANDA075051_001
12NDA018821REGLANTrueAH ROBINS CO1983-03-25NDA018821_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070819_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalse1987-07-10METOCLOPRAMIDE HYDROCHLORIDE
2ANDA070949_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalse1987-03-06METOCLOPRAMIDE HYDROCHLORIDE
3ANDA071315_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalse1993-06-30METOCLOPRAMIDE HYDROCHLORIDE
4ANDA071340_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalse1988-08-18METOCLOPRAMIDE HYDROCHLORIDE
5ANDA071402_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalseAA1993-06-25METOCLOPRAMIDE HYDROCHLORIDE
6ANDA071665_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalse1988-12-05METOCLOPRAMIDE HYDROCHLORIDE
7ANDA072038_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalse1988-12-05METOCLOPRAMIDE HYDROCHLORIDE
8ANDA072744_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalseAA1991-05-28METOCLOPRAMIDE HYDROCHLORIDE
9ANDA073680_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalseAA1992-10-27METOCLOPRAMIDE HYDROCHLORIDE
10ANDA074703_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONTrueAA1997-10-31METOCLOPRAMIDE HYDROCHLORIDE
11ANDA075051_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalseAA2001-01-26METOCLOPRAMIDE HYDROCHLORIDE
12NDA018821_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/5ML)ORALSOLUTIONFalse1983-03-25REGLAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13cc8ca5b-8b71-4c77-a181-9ce154597b9a (view SPL)METOCLOPRAMIDE ORAL SOLUTION USPprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2015-07-229001210576, 001211576
24e12e98a-06fe-4b3c-bb64-f2701e195c74 (view SPL)METOCLOPRAMIDE ORAL SOLUTION USP 5 mg/5 mL Rx OnlyprescriptionHuman PrescriptionAnip Acquisition Company2015-05-181625590190
359abd52d-8172-44a3-baa2-fe1fe20f78c0 (view SPL)METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mLprescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2012-04-035666890031
46cef9808-d867-4908-964b-c57ce500dccc (view SPL)Metoclopramide Oral Solution Rx onlyprescriptionHuman PrescriptionAnip Acquisition CompanyANALYSIS, MANUFACTURE2012-08-172625590110
57e727a97-3b40-46b9-af65-9bc5c220fe3e (view SPL)METOCLOPRAMIDE ORAL SOLUTION USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-12-092551549427
6a637c1ac-78d1-4d44-9c79-b6da9a8f2fb9 (view SPL)Metoclopramide Oral Solution, USP 5 mg/5 mLprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-03-219604320622
7baacecf3-b371-42c6-bf58-bd4141ddb665 (view SPL)METOCLOPRAMIDE ORAL SOLUTION, USPprescriptionHuman PrescriptionPrecision Dose Inc.2012-10-013680940676, 680940680
8cf6a64e0-98ac-46a6-8d2a-1dd963cc65c5 (view SPL)METOCLOPRAMIDE ORAL SOLUTION USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-07-242504360576

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