Carbamazepine

Treats pain associated with true trigeminal neuralgia. ANDA 74649, held by Taro. Carbamazepine.

As of Nov 15, 2026, ANDA 74649 (Carbamazepine), held by Taro, was first approved by FDA on Oct 3, 1996, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1996
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 3, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carbamazepine200MG · tablet;oral	Carbamazepine	Rx

All 17 submissions, including labeling and manufacturing supplements


Feb 28, 2020	Supplement 34Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 29Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 27Labeling · Standard review	Approved	None posted
Jun 13, 2013	Supplement 23Labeling · Standard review	Approved	None posted
Jan 24, 2012	Supplement 21Labeling	Approved	None posted
Nov 5, 2009	Supplement 19Labeling	Approved	None posted
Apr 21, 2008	Supplement 15Labeling	Approved	None posted
Mar 6, 2001	Supplement 8Labeling	Approved	None posted
Mar 6, 2001	Supplement 7Manufacturing	Approved	None posted
Feb 28, 2001	Supplement 9Labeling	Approved	None posted
Sep 22, 1999	Supplement 6Labeling	Approved	None posted
Mar 11, 1999	Supplement 5Labeling	Approved	None posted
Mar 11, 1999	Supplement 4Manufacturing	Approved	None posted
Sep 30, 1998	Supplement 3Manufacturing	Approved	None posted
Sep 30, 1998	Supplement 2Labeling	Approved	None posted
May 27, 1997	Supplement 1Manufacturing	Approved	None posted
Oct 3, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74649
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters