Fml

NDA 17760, held by Allergan. Fluorometholone.

As of Nov 13, 2026, NDA 17760 (Fml), held by Allergan, was first approved by FDA on Sep 4, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Sep 4, 1985
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Sep 4, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fml0.1% · ointment;ophthalmic	Fluorometholone	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Feb 12, 2013	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 12, 2007	Supplement 15Manufacturing · Standard review	Approved	Letter
Jul 13, 2001	Supplement 9Manufacturing · Standard review	Approved	Label Letter
Apr 12, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 9, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 7, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
May 11, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 11, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
May 21, 1992	Supplement 2Labeling	Approved	None posted
Mar 27, 1987	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 4, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17760
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

Fml