Carbamazepine

ANDA 71940, held by Jubilant Cadista. Carbamazepine.

As of Nov 15, 2026, ANDA 71940 (Carbamazepine), held by Jubilant Cadista, was first approved by FDA on Feb 1, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 1, 1988
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 1, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carbamazepine100MG · tablet, chewable;oral	Carbamazepine	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jun 18, 1997	Supplement 13Labeling	Approved	None posted
Jun 23, 1994	Supplement 11Manufacturing	Approved	None posted
Mar 8, 1994	Supplement 8Manufacturing	Approved	None posted
Jan 7, 1994	Supplement 10Manufacturing	Approved	None posted
Jan 7, 1994	Supplement 9Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 7Labeling	Approved	None posted
Mar 29, 1991	Supplement 6Labeling	Approved	None posted
Jan 3, 1990	Supplement 19Labeling	Approved	None posted
Jan 3, 1990	Supplement 4Labeling	Approved	None posted
Mar 10, 1989	Supplement 1Manufacturing	Approved	None posted
Feb 1, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71940
Drugs@FDA: Overview at FDA
Company: Jubilant Cadista 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