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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073524
Company: TEVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPITOL CARBAMAZEPINE 100MG TABLET, CHEWABLE;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
07/29/1992 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
07/22/2024 SUPPL-54 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/21/2022 SUPPL-53 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
02/27/2020 SUPPL-48 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
02/27/2020 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
02/06/2015 SUPPL-43 Labeling-Package Insert

Label is not available on this site.
02/06/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.
03/10/2014 SUPPL-39 Labeling-Package Insert

Label is not available on this site.
03/10/2014 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
10/23/2012 SUPPL-37 Labeling-Medication Guide

Label is not available on this site.
05/31/2011 SUPPL-36 REMS-Proposal, Labeling-Package Insert

Label is not available on this site.
01/21/2011 SUPPL-35 Labeling-Container/Carton Labels

Label is not available on this site.
03/17/2010 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
11/16/2009 SUPPL-31 Labeling

Label is not available on this site.
03/26/2008 SUPPL-30 Labeling

Label is not available on this site.
12/05/2002 SUPPL-27 Labeling

Label is not available on this site.
04/23/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
05/08/2002 SUPPL-24 Labeling

Label is not available on this site.
05/01/2000 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
12/02/1999 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.
12/02/1999 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.
08/13/1999 SUPPL-11 Labeling

Label is not available on this site.
02/12/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
02/12/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
09/24/1997 SUPPL-8 Labeling

Label is not available on this site.
02/04/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
12/02/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
07/25/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
02/09/1995 SUPPL-2 Labeling

Label is not available on this site.

EPITOL

TABLET, CHEWABLE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, CHEWABLE;ORAL Prescription No AB 075687 TARO PHARM INDS
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, CHEWABLE;ORAL Prescription No AB 075712 TORRENT PHARMS
EPITOL CARBAMAZEPINE 100MG TABLET, CHEWABLE;ORAL Prescription No AB 073524 TEVA
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