Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071696
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 200MG 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
11/09/1987 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
01/11/2008 SUPPL-36 Labeling

Label is not available on this site.

11/02/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-25 Labeling

Label is not available on this site.

05/01/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2000 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

03/20/2000 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

04/22/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/31/1999 SUPPL-20 Labeling

Label is not available on this site.

07/01/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/18/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/27/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/04/1998 SUPPL-16 Labeling

Label is not available on this site.

02/10/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/04/1998 SUPPL-14 Labeling

Label is not available on this site.

03/06/1997 SUPPL-13 Labeling

Label is not available on this site.

01/18/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-11 Labeling

Label is not available on this site.

09/13/1990 SUPPL-10 Labeling

Label is not available on this site.

03/02/1990 SUPPL-9 Labeling

Label is not available on this site.

08/31/1989 SUPPL-7 Labeling

Label is not available on this site.

05/17/1989 SUPPL-5 Bioequivalence

Label is not available on this site.

09/28/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/04/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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