Acetylcysteine

ANDA 203624, held by Rising. Acetylcysteine.

As of Nov 15, 2026, ANDA 203624 (Acetylcysteine), held by Rising, was not approved, with 3 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 17, 2015	Original application	Tentative approval	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetylcysteine6GM/30ML (200MG/ML) · injectable;intravenous	Acetylcysteine	None (tentative approval)

All 4 submissions, including labeling and manufacturing supplements


Sep 4, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Aug 21, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Aug 21, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 17, 2015	Original application	Tentative approval	None posted

Identifiers

Application: ANDA 203624
Drugs@FDA: Overview at FDA
Company: Rising 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