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Proscar

Treats symptomatic benign prostatic hyperplasia (BPH). NDA 20180, held by Organon. Finasteride.

As of Nov 13, 2026, NDA 20180 (Proscar), held by Organon, was first approved by FDA on Jun 19, 1992, with 40 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1992
Review: Priority
Supplements approved: 40
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). Limitations of Use: PROSCAR is not approved for the prevention of prostate cancer. 1.1 Monotherapy PROSCAR is

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below

Date	Submission	Status	Documents
Apr 12, 2004	Supplement 26Efficacy (new indication or use)	Approved	Review Letter Label
Mar 20, 1998	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Review
Mar 20, 1998	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review
Jun 19, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Proscar5MG · tablet;oral	Finasteride	RxReference drug

All 41 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 18, 2026	Supplement 50Labeling · Standard review	Approved	Label Letter
Aug 25, 2021	Supplement 49Labeling · Standard review	Approved	Label Letter
Jun 15, 2021	Supplement 47Labeling · Standard review	Approved	Label Letter
Apr 13, 2021	Supplement 48Labeling · Standard review	Approved	Label Letter
Jul 6, 2015	Supplement 45Manufacturing · Priority review	Approved	None posted
Mar 11, 2014	Supplement 44Labeling · Standard review	Approved	Letter Label
Jan 16, 2013	Supplement 43Labeling	Approved	Letter Label
Apr 11, 2012	Supplement 42Labeling	Approved	Letter Label
Apr 11, 2012	Supplement 41Labeling	Approved	Letter Label
Apr 11, 2012	Supplement 40Labeling	Approved	Letter Label
Jun 10, 2011	Supplement 35Labeling	Approved	Letter
Jun 9, 2011	Supplement 39Labeling	Approved	Letter Label
Oct 4, 2010	Supplement 37Labeling	Approved	Letter Label
Mar 23, 2010	Supplement 33Labeling	Approved	Letter Label
Apr 23, 2004	Supplement 29Labeling · Standard review	Approved	Review Label Letter
Apr 12, 2004	Supplement 26Efficacy (new indication or use)	Approved	Review Letter Label
Sep 23, 2003	Supplement 20Labeling · Standard review	Approved	Review Letter
Sep 9, 2003	Supplement 27Labeling · Standard review	Approved	Review Letter Label
Jun 26, 2003	Supplement 25Labeling · Standard review	Approved	Review Letter
Nov 26, 2002	Supplement 24Manufacturing · Priority review	Approved	Review
Oct 28, 2002	Supplement 23Manufacturing · Priority review	Approved	Review
Jan 30, 2001	Supplement 22Labeling · Standard review	Approved	Review
Jan 17, 2001	Supplement 19Labeling · Standard review	Approved	Review
Aug 2, 1999	Supplement 18Labeling · Standard review	Approved	Review
Mar 20, 1998	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Review
Mar 20, 1998	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review
Dec 19, 1997	Supplement 17Labeling · Standard review	Approved	Review
May 16, 1997	Supplement 14Manufacturing · Priority review	Approved	Review
May 12, 1997	Supplement 13Manufacturing · Priority review	Approved	Review
Aug 28, 1996	Supplement 11Labeling · Standard review	Approved	Review
Jul 24, 1996	Supplement 10Manufacturing · Priority review	Approved	Review
Dec 30, 1994	Supplement 9Labeling · Standard review	Approved	None posted
May 18, 1994	Supplement 8Labeling · Standard review	Approved	None posted
May 18, 1994	Supplement 7Labeling · Standard review	Approved	None posted
Sep 16, 1993	Supplement 6Manufacturing · Priority review	Approved	None posted
Sep 1, 1993	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 5, 1993	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 22, 1992	Supplement 3Labeling · Standard review	Approved	None posted
Dec 22, 1992	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 20, 1992	Supplement 1Labeling	Approved	None posted
Jun 19, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20180
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