Betamethasone Valerate

ANDA 70052, held by Pharmazone. Betamethasone Valerate.

As of Nov 15, 2026, ANDA 70052 (Betamethasone Valerate), held by Pharmazone, was first approved by FDA on Jul 31, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1985
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jul 31, 1985	Original application	Approved	None posted

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


Mar 5, 1992	Supplement 9Labeling	Approved	None posted
Sep 3, 1991	Supplement 10Manufacturing	Approved	None posted
Aug 2, 1991	Supplement 11Manufacturing	Approved	None posted
Aug 2, 1991	Supplement 12Manufacturing	Approved	None posted
Aug 2, 1991	Supplement 13Manufacturing	Approved	None posted
Oct 13, 1989	Supplement 8Labeling	Approved	None posted
Feb 15, 1989	Supplement 5Manufacturing	Approved	None posted
Feb 15, 1989	Supplement 6Manufacturing	Approved	None posted
Feb 15, 1989	Supplement 7Manufacturing	Approved	None posted
Dec 2, 1987	Supplement 4Manufacturing	Approved	None posted
Oct 9, 1986	Supplement 2Manufacturing	Approved	None posted
Jul 31, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70052
Drugs@FDA: Overview at FDA
Company: Pharmazone

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