Diprolene

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 18741, held by Organon. Betamethasone Dipropionate.

As of Nov 13, 2026, NDA 18741 (Diprolene), held by Organon, was first approved by FDA on Jul 27, 1983, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 27, 1983
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DIPROLENE Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Aug 28, 2006	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 27, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
DiproleneEQ 0.05% BASE · ointment, augmented;topical	Betamethasone Dipropionate	RxReference drug

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 1, 2019	Supplement 40Labeling · Standard review	Approved	Letter Label
Mar 28, 2018	Supplement 38Labeling · Standard review	Approved	Label Letter
Aug 13, 2014	Supplement 36Labeling · Standard review	Approved	Label Letter
Aug 28, 2006	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 7, 2005	Supplement 16Labeling	Approved	Label Letter Letter Label
Nov 10, 1998	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 31, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 15, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 15, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 30, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 8, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
May 24, 1989	Supplement 13Labeling	Approved	None posted
Nov 30, 1988	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 29, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 29, 1986	Supplement 1Labeling	Approved	None posted
Sep 12, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 23, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 22, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 16, 1984	Supplement 3Labeling	Approved	None posted
Dec 15, 1983	Supplement 2Labeling	Approved	None posted
Jul 27, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18741
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