Florone

NDA 17741, held by Pfizer. Diflorasone Diacetate.

As of Nov 13, 2026, NDA 17741 (Florone), held by Pfizer, was first approved by FDA on Sep 14, 1977, with 20 approved supplements and 0 published complete response letters.

First approved: Sep 14, 1977
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Sep 14, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Florone0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Diflorasone Diacetate	Discontinued

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 25, 2017	Supplement 24Labeling · Standard review	Approved	Letter Label
Dec 18, 2003	Supplement 22Labeling · Standard review	Approved	Label Letter
May 29, 2003	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 10, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
May 17, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
May 30, 1989	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 2, 1988	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 29, 1984	Supplement 14Labeling	Approved	None posted
Aug 20, 1982	Supplement 13Labeling	Approved	None posted
Aug 20, 1982	Supplement 12Labeling	Approved	None posted
Oct 21, 1981	Supplement 11Labeling	Approved	None posted
May 5, 1981	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 18, 1981	Supplement 8Labeling	Approved	None posted
Feb 18, 1981	Supplement 7Labeling	Approved	None posted
Feb 4, 1981	Supplement 1Labeling	Approved	None posted
Jan 16, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 24, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 16, 1979	Supplement 3Labeling	Approved	None posted
May 22, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 7, 1978	Supplement 2Labeling	Approved	None posted
Sep 14, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17741
Drugs@FDA: Overview at FDA
Company: Pfizer

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