Fluor-Op

ANDA 70185, held by Novartis. Fluorometholone.

As of Nov 15, 2026, ANDA 70185 (Fluor-Op), held by Novartis, was first approved by FDA on Feb 27, 1986, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 27, 1986
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 27, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluor-Op0.1% · suspension/drops;ophthalmic	Fluorometholone	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 19, 2001	Supplement 8Manufacturing	Approved	None posted
Oct 7, 1994	Supplement 5Manufacturing	Approved	None posted
Jun 10, 1994	Supplement 6Manufacturing	Approved	None posted
Mar 7, 1994	Supplement 4Labeling	Approved	None posted
Oct 20, 1992	Supplement 3Labeling	Approved	None posted
Jun 20, 1988	Supplement 2Labeling	Approved	None posted
Jun 10, 1986	Supplement 1Manufacturing	Approved	None posted
Feb 27, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70185
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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