Carbamazepine

ANDA 70231, held by Inwood Labs. Carbamazepine.

As of Nov 15, 2026, ANDA 70231 (Carbamazepine), held by Inwood Labs, was first approved by FDA on Aug 14, 1986, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 14, 1986
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 14, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carbamazepine200MG · tablet;oral	Carbamazepine	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Oct 5, 2000	Supplement 11Labeling	Approved	None posted
Dec 30, 1998	Supplement 10Labeling	Approved	None posted
Nov 23, 1998	Supplement 9Manufacturing	Approved	None posted
Aug 8, 1997	Supplement 8Labeling	Approved	None posted
Feb 22, 1993	Supplement 7Manufacturing	Approved	None posted
Dec 10, 1990	Supplement 6Labeling	Approved	None posted
Mar 7, 1990	Supplement 5Labeling	Approved	None posted
Oct 5, 1989	Supplement 3Labeling	Approved	None posted
Aug 14, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70231
Drugs@FDA: Overview at FDA
Company: Inwood Laboratories

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