Acetic Acid

ANDA 88638, held by Sun Pharma Canada. Acetic Acid, Glacial.

As of Nov 15, 2026, ANDA 88638 (Acetic Acid), held by Sun Pharma Canada, was first approved by FDA on Sep 6, 1984, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 6, 1984
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 6, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetic Acid2% · solution/drops;otic	Acetic Acid, Glacial	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Apr 30, 2001	Supplement 17Labeling	Approved	None posted
Nov 22, 1999	Supplement 16Labeling	Approved	None posted
Apr 6, 1993	Supplement 15Labeling	Approved	None posted
Mar 15, 1993	Supplement 14Labeling	Approved	None posted
Dec 20, 1989	Supplement 13Labeling	Approved	None posted
Aug 31, 1989	Supplement 12Manufacturing	Approved	None posted
Aug 29, 1988	Supplement 11Labeling	Approved	None posted
Aug 11, 1988	Supplement 10Labeling	Approved	None posted
Mar 1, 1988	Supplement 8Manufacturing	Approved	None posted
Aug 15, 1986	Supplement 6Manufacturing	Approved	None posted
Dec 4, 1985	Supplement 4Manufacturing	Approved	None posted
Nov 30, 1984	Supplement 3Manufacturing	Approved	None posted
Nov 30, 1984	Supplement 2Manufacturing	Approved	None posted
Oct 17, 1984	Supplement 1Manufacturing	Approved	None posted
Sep 6, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88638
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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