Diprolene

NDA 19408, held by Schering. Betamethasone Dipropionate.

As of Nov 13, 2026, NDA 19408 (Diprolene), held by Schering, was first approved by FDA on Jan 31, 1986, with 15 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1986
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jan 31, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
DiproleneEQ 0.05% BASE · cream, augmented;topical	Betamethasone Dipropionate	Discontinued
DiproleneEQ 0.05% BASE · gel, augmented;topical	Betamethasone Dipropionate	Discontinued

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2007	Supplement 15Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 9Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 3Labeling	Approved	None posted
May 14, 1999	Supplement 14Manufacturing · 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 12Manufacturing · Standard review	Approved	None posted
Jun 15, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 30, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 8, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 22, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
May 24, 1989	Supplement 4Labeling	Approved	None posted
Feb 24, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
May 13, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19408
Drugs@FDA: Overview at FDA
Company: Schering 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