Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076729
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERIL 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
09/20/2004 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
11/08/2016 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/13/2013 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

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.

01/27/2010 SUPPL-4 Labeling

Label is not available on this site.

04/17/2008 SUPPL-2 Labeling

Label is not available on this site.

TERIL

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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