Beta-Val

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 18642, held by Cosette Pharms Nc. Betamethasone Valerate.

As of Nov 13, 2026, NDA 18642 (Beta-Val), held by Cosette Pharms Nc, was first approved by FDA on Mar 24, 1983, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 24, 1983
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 24, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Beta-ValEQ 0.1% BASE · cream;topical	Betamethasone Valerate	Rx

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 22, 2016	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 30, 2001	Supplement 22Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 21Manufacturing	Approved	None posted
Jan 12, 2000	Supplement 20Manufacturing	Approved	None posted
Jun 13, 1996	Supplement 19Manufacturing	Approved	None posted
Jul 14, 1995	Supplement 18Manufacturing	Approved	None posted
May 4, 1995	Supplement 17Manufacturing	Approved	None posted
May 4, 1995	Supplement 16Manufacturing	Approved	None posted
Dec 9, 1994	Supplement 15Manufacturing	Approved	None posted
Dec 9, 1994	Supplement 14Manufacturing	Approved	None posted
Dec 9, 1994	Supplement 13Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 12Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 11Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 10Manufacturing	Approved	None posted
Oct 30, 1992	Supplement 9Manufacturing	Approved	None posted
Oct 30, 1992	Supplement 8Manufacturing	Approved	None posted
Jul 21, 1989	Supplement 5Manufacturing	Approved	None posted
Jul 15, 1988	Supplement 4Labeling	Approved	None posted
Sep 10, 1987	Supplement 3Manufacturing	Approved	None posted
Mar 24, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18642
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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