Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075712
Company: TORRENT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE 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
07/05/2001 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-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/19/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/19/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

06/19/2012 SUPPL-22 Labeling

Label is not available on this site.

09/27/2011 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

02/23/2010 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

05/27/2010 SUPPL-15 Labeling

Label is not available on this site.

02/23/2010 SUPPL-14 Labeling

Label is not available on this site.

02/11/2008 SUPPL-10 Labeling

Label is not available on this site.

12/17/2007 SUPPL-9 Labeling

Label is not available on this site.

10/01/2002 SUPPL-3 Labeling

Label is not available on this site.

10/01/2002 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

CARBAMAZEPINE

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
TEGRETOL CARBAMAZEPINE 100MG TABLET, CHEWABLE;ORAL Prescription Yes AB 018281 NOVARTIS

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