Last Updated: November 8, 2026

Details for New Drug Application (NDA): 091071

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NDA 091071 describes GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, and Sun Pharm Inds Inc, and is included in six NDAs. It is available from twenty-eight suppliers. Additional details are available on the GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE is guaifenesin; pseudoephedrine hydrochloride. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

Summary for 091071

Tradename:	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant:	Actavis Labs Fl
Ingredient:	guaifenesin; pseudoephedrine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG;60MG
Approval Date:	May 27, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.2GM;120MG
Approval Date:	May 27, 2015	TE:		RLD:	No

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