Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075051
Company: VISTAPHARM
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
01/26/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-051_Metoclopramide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-051_Metoclopramide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2012 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/30/2010 SUPPL-2 REMS-Proposal

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/26/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-051_Metoclopramide_prntlbl.pdf

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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