Acetylcysteine

ANDA 208166, held by Zydus Pharms. Acetylcysteine.

As of Nov 15, 2026, ANDA 208166 (Acetylcysteine), held by Zydus Pharms, was first approved by FDA on Jul 20, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 20, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetylcysteine6GM/30ML (200MG/ML) · injectable;intravenous	Acetylcysteine	Rx

All 3 submissions, including labeling and manufacturing supplements


Mar 4, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Mar 4, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jul 20, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 208166
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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