Acetylcysteine

ANDA 72621, held by Roxane. Acetylcysteine.

As of Nov 15, 2026, ANDA 72621 (Acetylcysteine), held by Roxane, was first approved by FDA on Sep 30, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1992
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 30, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetylcysteine10% · solution;inhalation, oral	Acetylcysteine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Aug 28, 2000	Supplement 5Manufacturing	Approved	None posted
May 27, 1999	Supplement 4Labeling	Approved	None posted
Apr 13, 1998	Supplement 2Manufacturing	Approved	None posted
Apr 13, 1998	Supplement 3Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 72621
Drugs@FDA: Overview at FDA
Company: Roxane Laboratories

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