Acetylcysteine

ANDA 73664, held by Hospira. Acetylcysteine.

As of Nov 15, 2026, ANDA 73664 (Acetylcysteine), held by Hospira, was first approved by FDA on Aug 30, 1994, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 30, 1994
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 30, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Jan 15, 2016	Supplement 18Labeling · Standard review	Approved	None posted
Aug 5, 1998	Supplement 6Labeling	Approved	None posted
Feb 5, 1996	Supplement 4Labeling	Approved	None posted
Feb 5, 1996	Supplement 3Manufacturing	Approved	None posted
Feb 5, 1996	Supplement 2Manufacturing	Approved	None posted
Feb 5, 1996	Supplement 1Manufacturing	Approved	None posted
Aug 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 73664
Drugs@FDA: Overview at FDA
Company: Hospira

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