Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071402
Company: ANI PHARMS
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
06/25/1993 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
07/28/2015 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

07/31/2012 SUPPL-11 Labeling-Medication Guide, REMS-Modified

Label is not available on this site.

02/28/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

03/31/2010 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

09/16/2009 SUPPL-8 Labeling, REMS-Modified Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/071402Orig1s008.pdf
06/30/2009 SUPPL-7 REMS-Proposal, Labeling, REMS-Modified Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/071402Orig1s007.pdf
10/28/2008 SUPPL-6 Labeling

Label is not available on this site.

12/16/2014 SUPPL-5 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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