Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075714
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION;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
06/05/2002 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
01/26/2012 SUPPL-7 Labeling-Medication Guide, REMS-Proposal

Label is not available on this site.

12/15/2009 SUPPL-5 Labeling

Label is not available on this site.

03/14/2008 SUPPL-4 Labeling

Label is not available on this site.

01/11/2008 SUPPL-3 Labeling

Label is not available on this site.

04/09/2004 SUPPL-2 Labeling

Label is not available on this site.

11/05/2003 SUPPL-1 Labeling

Label is not available on this site.

CARBAMAZEPINE

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription No AB 075714 WOCKHARDT BIO AG
TEGRETOL CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription Yes AB 018927 NOVARTIS
TERIL CARBAMAZEPINE 100MG/5ML SUSPENSION;ORAL Prescription No AB 076729 TARO

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