An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075712
Company: TORRENT PHARMS

Healthcare Professional Sheet

Products on ANDA 075712

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075712

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/2001	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
03/03/2021	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/03/2021	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
01/20/2015	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/20/2015	SUPPL-26	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/19/2014	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
02/19/2014	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/19/2012	SUPPL-22	Labeling		Label is not available on this site.
09/27/2011	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels		Label is not available on this site.
02/23/2010	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/27/2010	SUPPL-15	Labeling		Label is not available on this site.
02/23/2010	SUPPL-14	Labeling		Label is not available on this site.
02/11/2008	SUPPL-10	Labeling		Label is not available on this site.
12/17/2007	SUPPL-9	Labeling		Label is not available on this site.
10/01/2002	SUPPL-3	Labeling		Label is not available on this site.
10/01/2002	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/25/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075712

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

Top