Guaifenesin

ANDA 78912, held by Perrigo R And D. Guaifenesin.

As of Nov 15, 2026, ANDA 78912 (Guaifenesin), held by Perrigo R And D, was first approved by FDA on Nov 23, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 23, 2011
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 23, 2011	Original application	Approved	None posted

Products

2 strengths and forms


Guaifenesin600MG · tablet, extended release;oral	Guaifenesin	OTC
Guaifenesin1.2GM · tablet, extended release;oral	Guaifenesin	OTC

All 6 submissions, including labeling and manufacturing supplements


May 23, 2025	Supplement 23Manufacturing	Approved	None posted
Apr 15, 2025	Supplement 21Manufacturing	Approved	None posted
Jan 13, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Jan 13, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Mar 12, 2015	Supplement 1Manufacturing	Approved	None posted
Nov 23, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78912
Drugs@FDA: Overview at FDA
Company: Perrigo R&D

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