Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077878
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB No No
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB 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
08/28/2006 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
08/13/2012 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/30/2010 SUPPL-3 Labeling-Medication Guide

Label is not available on this site.

04/30/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

METOCLOPRAMIDE HYDROCHLORIDE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 071250 IMPAX LABS INC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 078807 IPCA LABS LTD
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 072801 TEVA
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 077878 VINTAGE PHARMS
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 017854 ANI PHARMS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 071250 IMPAX LABS INC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 078807 IPCA LABS LTD
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 070581 PAR PHARM INC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 070184 TEVA
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077878 VINTAGE PHARMS
REGLAN METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 017854 ANI PHARMS

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