Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072744
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/1991 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/31/2014 SUPPL-16 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

09/10/2012 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/28/2014 SUPPL-14 Labeling-Container/Carton Labels

Label is not available on this site.

02/28/2011 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

09/15/2009 SUPPL-11 Labeling, REMS-Proposal Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/072744Orig1s011.pdf
07/02/2009 SUPPL-10 Labeling, REMS-Proposal Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/072744Orig1s010.pdf
06/27/2002 SUPPL-6 Labeling

Label is not available on this site.

05/12/1995 SUPPL-5 Labeling

Label is not available on this site.

05/20/1994 SUPPL-2 Labeling

Label is not available on this site.

09/29/1993 SUPPL-1 Labeling

Label is not available on this site.

METOCLOPRAMIDE HYDROCHLORIDE

SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 071402 ANI PHARMS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 072744 PHARM ASSOC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075051 VISTAPHARM
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 074703 WOCKHARDT BIO AG

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