Diprolene Af

NDA 19555, held by Organon. Betamethasone Dipropionate.

As of Nov 13, 2026, NDA 19555 (Diprolene Af), held by Organon, was first approved by FDA on Apr 27, 1987, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 27, 1987
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Aug 28, 2006	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 3, 2001	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Apr 27, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diprolene AfEQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream, augmented;topical	Betamethasone Dipropionate	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 1, 2019	Supplement 35Labeling · Standard review	Approved	Letter Label
Mar 28, 2018	Supplement 34Labeling · Standard review	Approved	Label Letter
Aug 13, 2014	Supplement 33Labeling · Standard review	Approved	Label Letter
Aug 28, 2006	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 3, 2001	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Oct 3, 2001	Supplement 8Labeling	Approved	Letter Review Label
Apr 4, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 14, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
May 14, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 7, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 10, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 31, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 15, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 30, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 29, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
May 24, 1989	Supplement 5Labeling	Approved	None posted
Nov 8, 1988	Supplement 4Labeling	Approved	None posted
Oct 29, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 27, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19555
Drugs@FDA: Overview at FDA
Company: Organon

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