Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071536
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Discontinued None No No
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None 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
04/28/1993 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
05/09/2012 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

05/24/2010 SUPPL-41 Labeling-Medication Guide

Label is not available on this site.

05/24/2010 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

09/07/2006 SUPPL-34 Labeling

Label is not available on this site.

01/02/2004 SUPPL-29 Labeling

Label is not available on this site.

06/30/2003 SUPPL-24 Labeling

Label is not available on this site.

12/09/2002 SUPPL-20 Labeling

Label is not available on this site.

06/27/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2002 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/07/2002 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/2002 SUPPL-12 Labeling

Label is not available on this site.

05/16/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

04/11/2000 SUPPL-10 Labeling

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-5 Labeling

Label is not available on this site.

01/16/1997 SUPPL-4 Manufacturing (CMC)-New Strength

Label is not available on this site.

01/16/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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