Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070541
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPITOL CARBAMAZEPINE 200MG 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
09/17/1986 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
01/20/2015 SUPPL-58 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

03/10/2014 SUPPL-55 Labeling-Package Insert

Label is not available on this site.

03/10/2014 SUPPL-54 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/19/2012 SUPPL-53 Labeling-Medication Guide

Label is not available on this site.

05/31/2011 SUPPL-52 REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

07/09/2013 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

11/04/2009 SUPPL-47 Labeling

Label is not available on this site.

03/17/2008 SUPPL-46 Labeling

Label is not available on this site.

12/05/2002 SUPPL-45 Labeling

Label is not available on this site.

05/08/2002 SUPPL-44 Labeling

Label is not available on this site.

08/01/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2002 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

05/01/2000 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1999 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

08/13/1999 SUPPL-32 Labeling

Label is not available on this site.

02/12/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/24/1997 SUPPL-28 Labeling

Label is not available on this site.

06/15/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/01/1997 SUPPL-26 Labeling

Label is not available on this site.

09/24/1997 SUPPL-25 Labeling

Label is not available on this site.

01/23/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/25/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/09/1995 SUPPL-21 Labeling

Label is not available on this site.

02/18/1993 SUPPL-19 Labeling

Label is not available on this site.

01/23/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/30/1990 SUPPL-17 Labeling

Label is not available on this site.

01/19/1990 SUPPL-16 Labeling

Label is not available on this site.

06/09/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/05/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/09/1989 SUPPL-12 Labeling

Label is not available on this site.

04/07/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-10 Labeling

Label is not available on this site.

04/07/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/23/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/16/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/11/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/11/1988 SUPPL-5 Labeling

Label is not available on this site.

03/11/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/09/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/17/1987 SUPPL-2 Labeling

Label is not available on this site.

12/17/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

EPITOL

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 075948 APOTEX INC
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 074649 TARO
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 077272 TORRENT PHARMS
EPITOL CARBAMAZEPINE 200MG TABLET;ORAL Prescription No AB 070541 TEVA
TEGRETOL CARBAMAZEPINE 200MG TABLET;ORAL Prescription Yes AB 016608 NOVARTIS

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