Mucosil-10

ANDA 70575, held by Dey. Acetylcysteine.

As of Nov 15, 2026, ANDA 70575 (Mucosil-10), held by Dey, was first approved by FDA on Oct 14, 1986, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 14, 1986
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 14, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mucosil-1010% · solution;inhalation, oral	Acetylcysteine	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Jun 14, 2001	Supplement 24Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 26Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 25Manufacturing	Approved	None posted
Jun 25, 1999	Supplement 23Labeling	Approved	None posted
Nov 25, 1998	Supplement 20Labeling	Approved	None posted
Feb 20, 1998	Supplement 19Labeling	Approved	None posted
Sep 5, 1997	Supplement 18Manufacturing	Approved	None posted
Apr 24, 1996	Supplement 17Manufacturing	Approved	None posted
Mar 11, 1994	Supplement 16Manufacturing	Approved	None posted
Jun 29, 1992	Supplement 15Labeling	Approved	None posted
Oct 26, 1990	Supplement 14Labeling	Approved	None posted
Aug 1, 1989	Supplement 13Manufacturing	Approved	None posted
Apr 20, 1989	Supplement 11Manufacturing	Approved	None posted
Sep 29, 1988	Supplement 10Labeling	Approved	None posted
Apr 20, 1988	Supplement 6Labeling	Approved	None posted
Jun 16, 1987	Supplement 3Manufacturing	Approved	None posted
Jun 16, 1987	Supplement 2Manufacturing	Approved	None posted
Jun 16, 1987	Supplement 1Manufacturing	Approved	None posted
Jan 22, 1987	Supplement 5Manufacturing	Approved	None posted
Oct 14, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70575
Drugs@FDA: Overview at FDA
Company: Dey Pharma

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