Acetylcysteine

For acute ingestion or from repeated supratherapeutic ingestion (RSI). ANDA 91684, held by Sagent Pharms Inc. Acetylcysteine.

As of Nov 15, 2026, ANDA 91684 (Acetylcysteine), held by Sagent Pharms Inc, was first approved by FDA on Oct 31, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2017
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 31, 2017	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


Feb 5, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Dec 17, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Oct 31, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 91684
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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