Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075687
Company: TARO PHARM INDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, CHEWABLE;ORAL Prescription AB No No
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, CHEWABLE;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/24/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75687ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2016 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-22 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/13/2013 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/24/2012 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels

Label is not available on this site.

01/27/2010 SUPPL-12 Labeling

Label is not available on this site.

04/17/2008 SUPPL-11 Labeling

Label is not available on this site.

07/29/2002 SUPPL-2 Labeling

Label is not available on this site.

07/29/2002 SUPPL-1 Manufacturing (CMC)-New Strength

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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