Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075948
Company: APOTEX INC
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
02/27/2002 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
02/18/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/18/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/18/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

02/18/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/04/2011 SUPPL-7 REMS-Proposal

Label is not available on this site.

11/25/2009 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/28/2008 SUPPL-3 Labeling

Label is not available on this site.

10/15/2002 SUPPL-1 Manufacturing (CMC)-Control

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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