Valisone

NDA 16740, held by Schering. Betamethasone Valerate.

As of Nov 13, 2026, NDA 16740 (Valisone), held by Schering, was first approved by FDA on Feb 17, 1969, with 15 approved supplements and 0 published complete response letters.

First approved: Feb 17, 1969
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
Feb 17, 1969	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ValisoneEQ 0.1% BASE · ointment;topical	Betamethasone Valerate	Discontinued

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 8, 1991	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 12, 1986	Supplement 17Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 23, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 7, 1986	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 22, 1982	Supplement 10Labeling · Standard review	Approved	None posted
Apr 16, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 15, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 15, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 3, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 17, 1980	Supplement 6Labeling · Standard review	Approved	None posted
Dec 26, 1979	Supplement 9Labeling · Standard review	Approved	None posted
May 31, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 6, 1977	Supplement 5Manufacturing · Standard review	Approved	None posted
May 31, 1974	Supplement 4	Approved	None posted
Feb 17, 1969	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16740
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