Propecia

NDA 20788, held by Organon. Finasteride.

As of Nov 13, 2026, NDA 20788 (Propecia), held by Organon, was first approved by FDA on Dec 19, 1997, with 23 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1997
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. PROPECIA is not indicated for use in women.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Apr 10, 2002	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 19, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propecia1MG · tablet;oral	Finasteride	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Aug 1, 2022	Supplement 30Labeling · Standard review	Approved	Label Letter
Jun 15, 2021	Supplement 28Labeling · Standard review	Approved	Letter Label
Jan 11, 2016	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 31, 2014	Supplement 24Labeling · Standard review	Approved	Letter Label
Apr 11, 2012	Supplement 23Labeling	Approved	Review Letter Label
Apr 11, 2012	Supplement 21Labeling	Approved	Review Letter Label
Apr 11, 2012	Supplement 20Labeling	Approved	Review Letter Label
Jun 10, 2011	Supplement 16Labeling	Approved	Letter
Jun 9, 2011	Supplement 22Labeling	Approved	Letter Label
Apr 13, 2011	Supplement 18Labeling	Approved	Review Letter Label
Mar 11, 2011	Supplement 17Labeling	Approved	Review Letter Label
Mar 24, 2010	Supplement 15Labeling	Approved	Letter Label
Nov 1, 2006	Supplement 14Manufacturing	Approved	None posted
Oct 21, 2004	Supplement 11Labeling · Standard review	Approved	Label Letter
Oct 21, 2004	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 21, 2004	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 30, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 10, 2002	Supplement 5Labeling · Standard review	Approved	Letter Label
Apr 10, 2002	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 8, 2001	Supplement 3Labeling · Standard review	Approved	Label
Jul 18, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 3, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 19, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20788
Drugs@FDA: Overview at FDA
Company: Organon

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