Flomax

NDA 20579, held by Sanofi. Tamsulosin Hydrochloride.

As of Nov 13, 2026, NDA 20579 (Flomax), held by Sanofi, was first approved by FDA on Apr 15, 1997, with 25 approved supplements and 0 published complete response letters.

First approved: Apr 15, 1997
Review: Standard
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below


Dec 22, 2009	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Label Letter
Apr 15, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Flomax0.4MG · capsule;oral	Tamsulosin Hydrochloride	DiscontinuedReference drug

All 26 submissions, including labeling and manufacturing supplements


Jan 23, 2019	Supplement 33Labeling · Standard review	Approved	Letter Label
Jan 21, 2016	Supplement 31Manufacturing · Standard review	Approved	None posted
Oct 20, 2014	Supplement 29Labeling · Standard review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Jul 20, 2014	Supplement 28Labeling · Standard review	Approved	Letter Label
Jul 25, 2011	Supplement 27Labeling	Approved	Letter Label
Dec 22, 2009	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 29, 2009	Supplement 25Labeling · Standard review	Approved	Letter Label
Dec 2, 2008	Supplement 24Labeling · Standard review	Approved	Letter
Apr 29, 2008	Supplement 23Labeling · Standard review	Approved	Letter
Feb 16, 2007	Supplement 21Labeling · Standard review	Approved	Letter Label
Jan 11, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Oct 18, 2005	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 18, 2005	Supplement 17Labeling · Standard review	Approved	None posted
Dec 17, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 20, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 6, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
May 1, 2001	Supplement 7Labeling · Standard review	Approved	None posted
Jul 26, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 30, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 2, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 23, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 19, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 8, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
May 26, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Aug 25, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 15, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20579
Drugs@FDA: Overview at FDA
Company: Sanofi

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