Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078115
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE;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
03/31/2009 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078115s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078115Orig1s000BioeqR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/13/2013 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/24/2012 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

02/23/2010 SUPPL-2 Labeling

Label is not available on this site.

CARBAMAZEPINE

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 078115 TARO
CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205571 ZYDUS PHARMS
TEGRETOL-XR CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020234 NOVARTIS

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 078115 TARO
CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205571 ZYDUS PHARMS
TEGRETOL-XR CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020234 NOVARTIS

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078115 TARO
CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205571 ZYDUS PHARMS
TEGRETOL-XR CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020234 NOVARTIS

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