Accutane

NDA 18662, held by Hoffmann La Roche. Isotretinoin.

As of Nov 14, 2026, NDA 18662 (Accutane), held by Hoffmann La Roche, was first approved by FDA on May 7, 1982, with 54 approved supplements and 0 published complete response letters.

First approved: May 7, 1982
Review: Priority
Supplements approved: 54
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 55 submissions below


May 2, 2002	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 6, 1986	Supplement 14Efficacy (new indication or use) · Priority review	Approved	None posted
May 7, 1982	Original applicationNew molecular entity · Priority review	Approved	Other

Products

3 strengths and forms


Accutane10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Isotretinoin	DiscontinuedReference drug
Accutane40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Isotretinoin	DiscontinuedReference drug
Accutane20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Isotretinoin	DiscontinuedReference drug

All 55 submissions, including labeling and manufacturing supplements


Oct 22, 2010	Supplement 61Labeling · Priority review	Approved	Letter Medication Guide
Feb 1, 2010	Supplement 60Labeling · Priority review	Approved	Letter Label
Nov 19, 2008	Supplement 59Labeling · Priority review	Approved	Label Letter
Oct 3, 2007	Supplement 58Labeling · Priority review	Approved	Letter Label
Jan 13, 2006	Supplement 57	Approved	Review
Aug 12, 2005	Supplement 56Labeling · Priority review	Approved	Review Letter Label
Aug 10, 2005	Supplement 55	Approved	Review
Aug 24, 2004	Supplement 54Labeling · Priority review	Approved	Review Label Letter
Mar 26, 2004	Supplement 53Manufacturing · Priority review	Approved	Review
Aug 27, 2003	Supplement 52Labeling · Priority review	Approved	Review Letter Label
Aug 27, 2003	Supplement 48Labeling · Priority review	Approved	Review Label Letter
Jun 20, 2002	Supplement 51Labeling · Priority review	Approved	Letter Label
May 2, 2002	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 12, 2002	Supplement 47Labeling · Priority review	Approved	Letter Patient Package Insert
Feb 15, 2002	Supplement 46Labeling · Priority review	Approved	Letter Label
Dec 31, 2001	Supplement 45Labeling · Priority review	Approved	Letter Label
Dec 31, 2001	Supplement 41Labeling · Priority review	Approved	Letter Label
Oct 30, 2001	Supplement 44Labeling · Priority review	Approved	Letter Label
Jan 11, 2001	Supplement 42Manufacturing · Priority review	Approved	Review
May 1, 2000	Supplement 40Labeling · Priority review	Approved	Letter
May 1, 2000	Supplement 39Labeling · Priority review	Approved	Letter
May 1, 2000	Supplement 38Labeling · Priority review	Approved	Review Letter
Apr 30, 1999	Supplement 37Manufacturing · Priority review	Approved	None posted
May 17, 1995	Supplement 34Labeling · Priority review	Approved	None posted
Jan 13, 1994	Supplement 33Labeling · Priority review	Approved	None posted
Oct 8, 1991	Supplement 32Manufacturing · Priority review	Approved	None posted
Mar 7, 1991	Supplement 30Labeling · Priority review	Approved	None posted
Oct 16, 1990	Supplement 31Manufacturing · Priority review	Approved	None posted
Apr 16, 1990	Supplement 29Labeling · Priority review	Approved	None posted
Aug 9, 1989	Supplement 28Manufacturing · Priority review	Approved	None posted
Apr 28, 1989	Supplement 26Manufacturing · Priority review	Approved	None posted
Apr 4, 1989	Supplement 27Manufacturing · Priority review	Approved	None posted
Nov 16, 1988	Supplement 25Manufacturing · Priority review	Approved	None posted
Aug 26, 1988	Supplement 24Labeling · Priority review	Approved	None posted
Jan 7, 1988	Supplement 23Manufacturing · Priority review	Approved	None posted
Oct 19, 1987	Supplement 22Labeling · Priority review	Approved	None posted
Jun 3, 1987	Supplement 21Manufacturing · Priority review	Approved	None posted
Jun 1, 1987	Supplement 20Labeling · Priority review	Approved	None posted
Feb 26, 1987	Supplement 19Manufacturing · Priority review	Approved	None posted
Jun 6, 1986	Supplement 18Labeling · Priority review	Approved	None posted
Jun 6, 1986	Supplement 17Labeling · Priority review	Approved	None posted
Jun 6, 1986	Supplement 14Efficacy (new indication or use) · Priority review	Approved	None posted
Jun 6, 1986	Supplement 10Labeling · Priority review	Approved	None posted
Jun 6, 1986	Supplement 3Labeling · Priority review	Approved	None posted
Jun 6, 1986	Supplement 1Labeling · Priority review	Approved	None posted
Jul 5, 1985	Supplement 16Labeling · Priority review	Approved	None posted
Jun 19, 1985	Supplement 7Manufacturing · Priority review	Approved	None posted
Apr 30, 1985	Supplement 15Labeling · Priority review	Approved	None posted
Nov 27, 1984	Supplement 13Manufacturing · Priority review	Approved	None posted
Nov 1, 1984	Supplement 11Manufacturing · Priority review	Approved	None posted
May 31, 1984	Supplement 9Manufacturing · Priority review	Approved	None posted
Feb 28, 1984	Supplement 8Labeling · Priority review	Approved	None posted
Aug 9, 1983	Supplement 4Labeling · Priority review	Approved	None posted
Jun 30, 1983	Supplement 2Manufacturing · Priority review	Approved	None posted
May 7, 1982	Original applicationNew molecular entity · Priority review	Approved	Other

Show all 55

Identifiers

Application: NDA 18662
Drugs@FDA: Overview at FDA
Company: Hoffmann-La 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