Betamethasone Valerate

ANDA 71883, held by Teva Pharms. Betamethasone Valerate.

As of Nov 15, 2026, ANDA 71883 (Betamethasone Valerate), held by Teva Pharms, was first approved by FDA on Apr 22, 1988, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1988
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 22, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Betamethasone ValerateEQ 0.1% BASE · lotion;topical	Betamethasone Valerate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jun 17, 1999	Supplement 6Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 5Manufacturing	Approved	None posted
Jun 11, 1998	Supplement 4Manufacturing	Approved	None posted
May 31, 1996	Supplement 3Manufacturing	Approved	None posted
Oct 30, 1992	Supplement 2Labeling	Approved	None posted
Jul 10, 1992	Supplement 1Manufacturing	Approved	None posted
Apr 22, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71883
Drugs@FDA: Overview at FDA
Company: Teva 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