Carbamazepine

Treats pain associated with true trigeminal neuralgia. ANDA 78115, held by Taro. Carbamazepine.

As of Nov 15, 2026, ANDA 78115 (Carbamazepine), held by Taro, was first approved by FDA on Mar 31, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 31, 2009
Supplements approved: 6
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 7 submissions below

Date	Submission	Status	Documents
Mar 31, 2009	Original application	Approved	Other Review Letter

Products

3 strengths and forms


Carbamazepine100MG · tablet, extended release;oral	Carbamazepine	Rx
Carbamazepine200MG · tablet, extended release;oral	Carbamazepine	Rx
Carbamazepine400MG · tablet, extended release;oral	Carbamazepine	Rx

All 7 submissions, including labeling and manufacturing supplements


Feb 28, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Jun 13, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Jan 24, 2012	Supplement 5Labeling	Approved	None posted
Feb 23, 2010	Supplement 2Labeling	Approved	None posted
Mar 31, 2009	Original application	Approved	Other Review Letter

Identifiers

Application: ANDA 78115
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