Acetasol

ANDA 87146, held by Actavis Mid Atlantic. Acetic Acid, Glacial.

As of Nov 15, 2026, ANDA 87146 (Acetasol), held by Actavis Mid Atlantic, was first approved by FDA on Aug 12, 1981, with 11 approved supplements and 0 published complete response letters.

First approved: Aug 12, 1981
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
Aug 12, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetasol2% · solution/drops;otic	Acetic Acid, Glacial	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Dec 29, 2000	Supplement 16Manufacturing	Approved	None posted
Aug 7, 1998	Supplement 15Labeling	Approved	None posted
Nov 17, 1993	Supplement 13Manufacturing	Approved	None posted
May 14, 1992	Supplement 12Manufacturing	Approved	None posted
Sep 28, 1990	Supplement 11Manufacturing	Approved	None posted
Dec 22, 1989	Supplement 8Labeling	Approved	None posted
Sep 15, 1987	Supplement 7Manufacturing	Approved	None posted
Dec 17, 1986	Supplement 5Manufacturing	Approved	None posted
Dec 17, 1986	Supplement 6Manufacturing	Approved	None posted
Jul 17, 1986	Supplement 4Manufacturing	Approved	None posted
Jan 13, 1984	Supplement 2Manufacturing	Approved	None posted
Aug 12, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87146
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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