Tegison

NDA 19369, held by Roche. Etretinate.

As of Nov 14, 2026, NDA 19369 (Tegison), held by Roche, was first approved by FDA on Sep 30, 1986, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1986
Review: Priority
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
Sep 30, 1986	Original applicationNew molecular entity · Priority review	Approved	Review

Products

2 strengths and forms


Tegison10MG · capsule;oral	Etretinate	Discontinued
Tegison25MG · capsule;oral	Etretinate	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Feb 16, 1995	Supplement 11Manufacturing · Priority review	Approved	None posted
Jan 12, 1994	Supplement 10Manufacturing · Priority review	Approved	None posted
Oct 8, 1991	Supplement 8Manufacturing · Priority review	Approved	None posted
Oct 16, 1990	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 31, 1988	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 5, 1988	Supplement 5Manufacturing · Priority review	Approved	None posted
May 27, 1988	Supplement 3Labeling	Approved	None posted
Mar 25, 1988	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 29, 1987	Supplement 1Labeling	Approved	None posted
Apr 2, 1987	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 30, 1986	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 19369
Drugs@FDA: Overview at FDA
Company: Roche

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