Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071250
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB No No
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG 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
02/03/1988 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
03/05/2012 SUPPL-34 Labeling-Package Insert, Labeling-Medication Guide, REMS-Modified

Label is not available on this site.

04/29/2010 SUPPL-31 REMS-Proposal

Label is not available on this site.

05/23/2002 SUPPL-15 Labeling

Label is not available on this site.

05/29/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

04/18/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/2001 SUPPL-12 Labeling

Label is not available on this site.

07/07/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

09/11/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-9 Labeling

Label is not available on this site.

06/27/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/21/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/19/1995 SUPPL-6 Labeling

Label is not available on this site.

11/03/1994 SUPPL-5 Labeling

Label is not available on this site.

05/11/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/30/1992 SUPPL-3 Labeling

Label is not available on this site.

07/02/1991 SUPPL-2 Labeling

Label is not available on this site.

METOCLOPRAMIDE HYDROCHLORIDE

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

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

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