Avodart

NDA 21319, held by Waylis Therap. Dutasteride.

As of Nov 14, 2026, NDA 21319 (Avodart), held by Waylis Therap, was first approved by FDA on Nov 20, 2001, with 18 approved supplements and 0 published complete response letters.

First approved: Nov 20, 2001
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jun 9, 2011	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 19, 2008	Supplement 14Efficacy (new indication or use)	Approved	Summary Review Label Letter
Sep 14, 2004	Supplement 8Efficacy (new indication or use)	Approved	Label Letter
Oct 9, 2002	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 20, 2001	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Avodart0.5MG · capsule;oral	Dutasteride	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Jan 30, 2020	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 10, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 30, 2013	Supplement 29Labeling · Standard review	Approved	Letter Label
Apr 30, 2013	Supplement 28Labeling	Approved	Letter Label
Jun 27, 2012	Supplement 27Labeling	Approved	Letter Label
Jun 9, 2011	Supplement 25Labeling	Approved	Label Letter
Jun 9, 2011	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 9, 2010	Supplement 22Labeling	Approved	Letter Label
Jun 15, 2010	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 19, 2008	Supplement 14Efficacy (new indication or use)	Approved	Summary Review Label Letter
Mar 31, 2008	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 23, 2005	Supplement 9Labeling · Standard review	Approved	Letter
Sep 14, 2004	Supplement 8Efficacy (new indication or use)	Approved	Label Letter
Aug 5, 2004	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 12, 2004	Supplement 5Labeling · Standard review	Approved	Letter
Dec 31, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 9, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 9, 2002	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 20, 2001	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 21319
Drugs@FDA: Overview at FDA
Company: Waylis Therapeutics

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