Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070184
Company: TEVA
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
07/29/1985 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
07/16/2019 SUPPL-69 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/10/2014 SUPPL-66 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-63 Labeling-Package Insert

Label is not available on this site.

03/31/2010 SUPPL-62 REMS-Proposal

Label is not available on this site.

07/28/2014 SUPPL-61 Labeling-Container/Carton Labels

Label is not available on this site.

11/16/2009 SUPPL-60 Labeling

Label is not available on this site.

01/17/2007 SUPPL-55 Labeling

Label is not available on this site.

08/12/2002 SUPPL-44 Labeling

Label is not available on this site.

11/13/2001 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/2001 SUPPL-41 Labeling

Label is not available on this site.

07/07/2000 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

12/22/1999 SUPPL-39 Labeling

Label is not available on this site.

10/27/1999 SUPPL-38 Labeling

Label is not available on this site.

01/27/2000 SUPPL-37 Manufacturing (CMC)-Facility

Label is not available on this site.

03/26/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/20/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/18/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/11/1996 SUPPL-33 Labeling

Label is not available on this site.

02/17/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/20/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/10/1994 SUPPL-26 Labeling

Label is not available on this site.

09/21/1993 SUPPL-25 Labeling

Label is not available on this site.

03/18/1993 SUPPL-24 Labeling

Label is not available on this site.

06/17/1992 SUPPL-23 Labeling

Label is not available on this site.

03/12/1991 SUPPL-22 Labeling

Label is not available on this site.

09/06/1990 SUPPL-19 Labeling

Label is not available on this site.

08/05/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/16/1988 SUPPL-17 Labeling

Label is not available on this site.

12/06/1988 SUPPL-16 Labeling

Label is not available on this site.

09/23/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/26/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/16/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/09/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/05/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/05/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/05/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/26/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/05/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/26/1986 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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