Alphagan

NDA 20613, held by Allergan. Brimonidine Tartrate.

As of Nov 14, 2026, NDA 20613 (Alphagan), held by Allergan, was first approved by FDA on Sep 6, 1996, with 21 approved supplements and 0 published complete response letters.

First approved: Sep 6, 1996
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Dec 20, 2001	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 6, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alphagan0.2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Brimonidine Tartrate	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Mar 23, 2016	Supplement 31Labeling · Standard review	Approved	Label Letter
Jun 6, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 19, 2003	Supplement 24Labeling · Standard review	Approved	None posted
May 16, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 12, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 20, 2001	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 4, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 13, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
May 14, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 9, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 9, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
May 26, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 13, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Dec 13, 1999	Supplement 6Labeling · Standard review	Approved	None posted
Aug 26, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
May 20, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 25, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 15, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
May 29, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 6, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20613
Drugs@FDA: Overview at FDA
Company: Allergan

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