Mucomyst

NDA 13601, held by Apothecon. Acetylcysteine.

As of Nov 13, 2026, NDA 13601 (Mucomyst), held by Apothecon, was first approved by FDA on Sep 14, 1963, with 27 approved supplements and 0 published complete response letters.

First approved: Sep 14, 1963
Review: Priority
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 46Efficacy (new indication or use)	Approved	None posted
Jan 31, 1985	Supplement 35Efficacy (new indication or use)	Approved	None posted
Sep 14, 1963	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Mucomyst20% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation, oral	Acetylcysteine	DiscontinuedReference drug
Mucomyst10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;inhalation, oral	Acetylcysteine	DiscontinuedReference drug

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 13, 2009	Supplement 37Labeling	Approved	None posted
Mar 13, 2009	Supplement 46Efficacy (new indication or use)	Approved	None posted
Mar 13, 2009	Supplement 49Labeling	Approved	None posted
Sep 24, 2001	Supplement 53Manufacturing · Priority review	Approved	None posted
Apr 21, 1997	Supplement 51Manufacturing · Priority review	Approved	None posted
Mar 19, 1997	Supplement 52Labeling · Standard review	Approved	None posted
Jul 13, 1993	Supplement 48Manufacturing · Priority review	Approved	None posted
Apr 5, 1991	Supplement 50Manufacturing · Priority review	Approved	None posted
Jan 16, 1987	Supplement 44Manufacturing · Priority review	Approved	None posted
Jun 18, 1986	Supplement 41Manufacturing · Priority review	Approved	None posted
Jan 31, 1985	Supplement 35Efficacy (new indication or use)	Approved	None posted
Mar 2, 1983	Supplement 39Manufacturing · Priority review	Approved	None posted
Nov 20, 1981	Supplement 36Manufacturing · Priority review	Approved	None posted
Feb 8, 1980	Supplement 28Manufacturing · Priority review	Approved	None posted
Jan 10, 1980	Supplement 34Manufacturing · Priority review	Approved	None posted
Jun 18, 1979	Supplement 33Manufacturing · Priority review	Approved	None posted
Apr 23, 1979	Supplement 32Manufacturing · Priority review	Approved	None posted
Sep 19, 1978	Supplement 31Manufacturing · Priority review	Approved	None posted
Sep 1, 1978	Supplement 29Labeling	Approved	Review
Aug 14, 1978	Supplement 30Manufacturing · Priority review	Approved	None posted
Dec 8, 1977	Supplement 26Manufacturing · Priority review	Approved	None posted
Oct 6, 1977	Supplement 25Manufacturing · Priority review	Approved	None posted
Sep 15, 1977	Supplement 24Manufacturing · Priority review	Approved	None posted
Sep 2, 1975	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 18, 1975	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 10, 1975	Supplement 19Manufacturing · Priority review	Approved	None posted
Aug 19, 1974	Supplement 18	Approved	None posted
Sep 14, 1963	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 13601
Drugs@FDA: Overview at FDA
Company: Apothecon

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