Fml Forte

NDA 19216, held by Abbvie. Fluorometholone.

As of Nov 13, 2026, NDA 19216 (Fml Forte), held by Abbvie, was first approved by FDA on Apr 23, 1986, with 24 approved supplements and 0 published complete response letters.

First approved: Apr 23, 1986
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Apr 23, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fml Forte0.25% · suspension/drops;ophthalmic	Fluorometholone	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Feb 13, 2025	Supplement 30Manufacturing	Approved	Label Letter
Feb 12, 2013	Supplement 25Labeling · Standard review	Approved	Label Letter
Jan 10, 2006	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 10, 2006	Supplement 21Manufacturing · Standard review	Approved	Letter Label
Sep 4, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 12, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 4, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 28, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 14, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
May 8, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 9, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 5, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 22, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 20, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
May 21, 1992	Supplement 7Labeling	Approved	None posted
May 18, 1990	Supplement 3Labeling	Approved	None posted
Feb 27, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 17, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 13, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 5, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 28, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 23, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19216
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