Diprolene

NDA 19716, held by Organon. Betamethasone Dipropionate.

As of Nov 14, 2026, NDA 19716 (Diprolene), held by Organon, was first approved by FDA on Aug 1, 1988, with 16 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1988
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Aug 28, 2006	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 1, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

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DiproleneEQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · lotion, augmented;topical	Betamethasone Dipropionate	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


May 1, 2019	Supplement 33Labeling · Standard review	Approved	Letter Label
Mar 28, 2018	Supplement 32Labeling · Standard review	Approved	Label Letter
Aug 13, 2014	Supplement 30Labeling · Standard review	Approved	Label Letter
Aug 28, 2006	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 24, 2006	Supplement 21Labeling · Standard review	Approved	Letter
Oct 7, 2005	Supplement 6Labeling	Approved	Letter Label
May 11, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 7, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
May 14, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 31, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 15, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 25, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 1, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
May 24, 1989	Supplement 3Labeling	Approved	None posted
Apr 6, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 1, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19716
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