Acetylcysteine

ANDA 71365, held by Hospira. Acetylcysteine.

As of Nov 15, 2026, ANDA 71365 (Acetylcysteine), held by Hospira, was first approved by FDA on Nov 20, 2007, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 20, 2007
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 20, 2007	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Nov 20, 2007	Original application	Approved	None posted
Nov 6, 2007	Supplement 12Labeling	Approved	None posted
Jan 18, 2002	Supplement 9Labeling	Approved	None posted
Jan 18, 2002	Supplement 8Manufacturing	Approved	None posted
Sep 17, 2001	Supplement 7Manufacturing	Approved	None posted
May 4, 2001	Supplement 6Manufacturing	Approved	None posted
Nov 18, 1998	Supplement 4Manufacturing	Approved	None posted
Jun 10, 1998	Supplement 5Labeling	Approved	None posted
Mar 13, 1998	Supplement 3Labeling	Approved	None posted

Identifiers

Application: ANDA 71365
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