Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074649
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE 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
10/03/1996 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
11/08/2016 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-27 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/13/2013 SUPPL-23 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/24/2012 SUPPL-21 Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

11/05/2009 SUPPL-19 Labeling

Label is not available on this site.

04/21/2008 SUPPL-15 Labeling

Label is not available on this site.

02/28/2001 SUPPL-9 Labeling

Label is not available on this site.

03/06/2001 SUPPL-8 Labeling

Label is not available on this site.

03/06/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/22/1999 SUPPL-6 Labeling

Label is not available on this site.

03/11/1999 SUPPL-5 Labeling

Label is not available on this site.

03/11/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/30/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/30/1998 SUPPL-2 Labeling

Label is not available on this site.

05/27/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CARBAMAZEPINE

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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