Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077272
Company: TORRENT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET;ORAL Prescription None No No
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET;ORAL Prescription AB No No
CARBAMAZEPINE CARBAMAZEPINE 300MG TABLET;ORAL Prescription None No No
CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET;ORAL Prescription 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
12/07/2005 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-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/19/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/19/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/19/2012 SUPPL-11 Labeling

Label is not available on this site.

01/24/2012 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

11/18/2009 SUPPL-7 Labeling

Label is not available on this site.

02/11/2008 SUPPL-4 Labeling

Label is not available on this site.

12/26/2007 SUPPL-3 Labeling

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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