Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070581
Company: PAR PHARM 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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/17/1985 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
07/30/2019 SUPPL-44 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/21/2012 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-37 Labeling-Package Insert, REMS-Proposal, Labeling-Medication Guide

Label is not available on this site.

03/11/2010 SUPPL-35 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/05/2005 SUPPL-27 Labeling

Label is not available on this site.

05/23/2002 SUPPL-22 Labeling

Label is not available on this site.

11/02/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2002 SUPPL-20 Labeling

Label is not available on this site.

05/26/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-18 Labeling

Label is not available on this site.

01/27/2000 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/18/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/28/1991 SUPPL-15 Labeling

Label is not available on this site.

07/10/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/01/1988 SUPPL-12 Labeling

Label is not available on this site.

11/23/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/15/1986 SUPPL-9 Labeling

Label is not available on this site.

06/23/1987 SUPPL-6 Labeling

Label is not available on this site.

06/15/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/25/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/25/1986 SUPPL-1 Manufacturing (CMC)

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

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