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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091070

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NDA 091070 describes GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Perrigo R And D, and Sun Pharm, and is included in six NDAs. It is available from sixty-one suppliers. Additional details are available on the GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.

Summary for 091070

Tradename:	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Applicant:	Actavis Labs Fl
Ingredient:	dextromethorphan hydrobromide; guaifenesin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG;600MG
Approval Date:	Aug 31, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG;1.2GM
Approval Date:	Aug 31, 2015	TE:		RLD:	No

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