Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072801
Company: TEVA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/15/1993 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
12/10/2014 SUPPL-41 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

03/31/2010 SUPPL-37 REMS-Proposal

Label is not available on this site.

09/22/2014 SUPPL-36 Labeling-Container/Carton Labels

Label is not available on this site.

11/06/2009 SUPPL-35 Labeling

Label is not available on this site.

01/24/2007 SUPPL-28 Labeling

Label is not available on this site.

08/12/2002 SUPPL-19 Labeling

Label is not available on this site.

11/13/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/2001 SUPPL-16 Labeling

Label is not available on this site.

07/07/2000 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

12/22/1999 SUPPL-14 Labeling

Label is not available on this site.

10/27/1999 SUPPL-13 Labeling

Label is not available on this site.

01/27/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

03/26/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/01/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/18/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/11/1996 SUPPL-8 Labeling

Label is not available on this site.

10/25/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/28/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/10/1994 SUPPL-2 Labeling

Label is not available on this site.

10/18/1993 SUPPL-1 Manufacturing (CMC)

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

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