Tretinoin

ANDA 76498, held by Zo Skin Health. Tretinoin.

As of Nov 15, 2026, ANDA 76498 (Tretinoin), held by Zo Skin Health, was first approved by FDA on Sep 15, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 15, 2005
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
Sep 15, 2005	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Mar 16, 2015	Supplement 10Labeling	Approved	None posted
Mar 12, 2009	Supplement 7Labeling	Approved	None posted
Dec 15, 2008	Supplement 6Labeling	Approved	None posted
Sep 15, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76498
Drugs@FDA: Overview at FDA
Company: ZO Skin Health

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