Fml

Treats corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva…. NDA 16851, held by Abbvie. Fluorometholone.

As of Nov 13, 2026, NDA 16851 (Fml), held by Abbvie, was first approved by FDA on Jan 12, 1972, with 41 approved supplements and 0 published complete response letters.

First approved: Jan 12, 1972
Review: Standard
Supplements approved: 41
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below

Date	Submission	Status	Documents
Jan 12, 1972	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fml0.1% · suspension/drops;ophthalmic	Fluorometholone	RxReference drug

All 42 submissions, including labeling and manufacturing supplements


Feb 12, 2013	Supplement 63Labeling · Standard review	Approved	Label Letter
Mar 19, 2003	Supplement 59Labeling · Standard review	Approved	None posted
Jul 18, 2002	Supplement 57Manufacturing · Standard review	Approved	None posted
Apr 12, 2002	Supplement 56Manufacturing · Standard review	Approved	None posted
Dec 4, 2001	Supplement 55Manufacturing · Standard review	Approved	None posted
Jul 24, 2001	Supplement 54Manufacturing · Standard review	Approved	None posted
Jun 28, 2001	Supplement 51Labeling · Standard review	Approved	Label Letter
Apr 12, 2001	Supplement 53Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 52Manufacturing · Standard review	Approved	None posted
Jun 30, 1998	Supplement 50Manufacturing · Standard review	Approved	None posted
May 1, 1998	Supplement 49Manufacturing · Standard review	Approved	None posted
Dec 18, 1996	Supplement 48Manufacturing · Standard review	Approved	None posted
Dec 5, 1996	Supplement 47Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 45Manufacturing · Standard review	Approved	None posted
Dec 22, 1994	Supplement 46Manufacturing · Standard review	Approved	None posted
Sep 20, 1993	Supplement 44Manufacturing · Standard review	Approved	None posted
Jun 8, 1993	Supplement 43Manufacturing · Standard review	Approved	None posted
May 20, 1992	Supplement 42Labeling	Approved	None posted
May 20, 1992	Supplement 38Labeling	Approved	None posted
Oct 12, 1989	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 27, 1989	Supplement 41Manufacturing · Standard review	Approved	None posted
Feb 1, 1989	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 18, 1986	Supplement 37Manufacturing · Standard review	Approved	None posted
May 31, 1984	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 14, 1983	Supplement 33Manufacturing · Standard review	Approved	None posted
Aug 13, 1982	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 28, 1982	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 28, 1982	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 30, 1980	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 27, 1979	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 9, 1979	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 20, 1978	Supplement 14Labeling	Approved	None posted
Sep 20, 1978	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 12, 1978	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 14, 1978	Supplement 17Labeling	Approved	None posted
Aug 14, 1978	Supplement 19Labeling	Approved	None posted
Aug 14, 1978	Supplement 21Labeling	Approved	None posted
Aug 14, 1978	Supplement 22Labeling	Approved	None posted
Aug 14, 1978	Supplement 23Labeling	Approved	None posted
Aug 14, 1978	Supplement 25Labeling	Approved	None posted
Feb 26, 1975	Supplement 13	Approved	None posted
Jan 12, 1972	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16851
Drugs@FDA: Overview at FDA
Company: AbbVie

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