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Last Updated: January 1, 2026

Details for New Drug Application (NDA): 091009

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NDA 091009 describes GUAIFENESIN, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Marksans Pharma, Ohm Labs Inc, Perrigo R And D, Sun Pharm, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc, and is included in twenty-one NDAs. It is available from eighty-five suppliers. Additional details are available on the GUAIFENESIN profile page.

The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

Summary for 091009

Tradename:	GUAIFENESIN
Applicant:	Actavis Labs Fl
Ingredient:	guaifenesin
Patents:	0

Medical Subject Heading (MeSH) Categories for 091009

Expectorants

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.2GM
Approval Date:	Sep 3, 2015	TE:		RLD:	No

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