Carbamazepine

Treats pain associated with true trigeminal neuralgia. ANDA 75687, held by Taro Pharm Inds. Carbamazepine.

As of Nov 15, 2026, ANDA 75687 (Carbamazepine), held by Taro Pharm Inds, was first approved by FDA on Oct 24, 2000, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 24, 2000
Supplements approved: 9
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 10 submissions below

Date	Submission	Status	Documents
Oct 24, 2000	Original application	Approved	Letter

Products

2 strengths and forms


Carbamazepine100MG · tablet, chewable;oral	Carbamazepine	Rx
Carbamazepine200MG · tablet, chewable;oral	Carbamazepine	Rx

All 10 submissions, including labeling and manufacturing supplements


Feb 28, 2020	Supplement 28Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 23Labeling · Standard review	Approved	None posted
Jun 13, 2013	Supplement 17Labeling · Standard review	Approved	None posted
Jan 24, 2012	Supplement 15Labeling	Approved	None posted
Jan 27, 2010	Supplement 12Labeling	Approved	None posted
Apr 17, 2008	Supplement 11Labeling	Approved	None posted
Jul 29, 2002	Supplement 1Manufacturing	Approved	None posted
Jul 29, 2002	Supplement 2Labeling	Approved	None posted
Oct 24, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75687
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceutical Industries

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