Tretinoin

ANDA 74873, held by Teva Pharms. Tretinoin.

As of Nov 15, 2026, ANDA 74873 (Tretinoin), held by Teva Pharms, was first approved by FDA on Jun 19, 1998, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1998
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 19, 1998	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tretinoin0.05% · solution;topical	Tretinoin	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jan 23, 2002	Supplement 3Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 4Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 5Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 6Manufacturing	Approved	None posted
Feb 26, 2001	Supplement 2Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 1Manufacturing	Approved	None posted
Jun 19, 1998	Original application	Approved	Review Letter

Identifiers

Application: ANDA 74873
Drugs@FDA: Overview at FDA
Company: Teva 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