Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071340
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;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
08/18/1988 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
04/11/2003 SUPPL-23 Labeling

Label is not available on this site.

10/30/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/2001 SUPPL-20 Labeling

Label is not available on this site.

07/31/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2000 SUPPL-18 Labeling

Label is not available on this site.

10/21/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/21/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/20/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/12/1996 SUPPL-13 Labeling

Label is not available on this site.

09/15/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/25/1993 SUPPL-10 Labeling

Label is not available on this site.

03/29/1993 SUPPL-9 Labeling

Label is not available on this site.

09/27/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/02/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/05/1990 SUPPL-5 Labeling

Label is not available on this site.

09/27/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/27/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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