Tretinoin

ANDA 77684, held by Barr Labs Inc. Tretinoin.

As of Nov 15, 2026, ANDA 77684 (Tretinoin), held by Barr Labs Inc, was first approved by FDA on Jun 21, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 21, 2007
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 21, 2007	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tretinoin10MG · capsule;oral	Tretinoin	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 24, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Feb 24, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Aug 24, 2009	Supplement 3Labeling	Approved	None posted
Jun 21, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 77684
Drugs@FDA: Overview at FDA
Company: Barr 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