Acetylcysteine

ANDA 72324, held by Roxane. Acetylcysteine.

As of Nov 15, 2026, ANDA 72324 (Acetylcysteine), held by Roxane, was first approved by FDA on Apr 30, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 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
Apr 30, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetylcysteine20% · solution;inhalation, oral	Acetylcysteine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 8, 2011	Supplement 14Labeling	Approved	None posted
Apr 3, 2001	Supplement 5Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 4Manufacturing	Approved	None posted
Jun 18, 1996	Supplement 3Manufacturing	Approved	None posted
May 23, 1995	Supplement 2Manufacturing	Approved	None posted
Apr 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 72324
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