Details for New Drug Application (NDA): 209215

NDA 209215 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 seventy-eight 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. Thirty-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

Summary for 209215

Tradename:	GUAIFENESIN
Applicant:	Guardian Drug
Ingredient:	guaifenesin
Patents:	0

Pharmacology for NDA: 209215

Physiological Effect

Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Medical Subject Heading (MeSH) Categories for 209215

Expectorants

Suppliers and Packaging for NDA: 209215

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	209215	ANDA	Major Pharmaceuticals	0904-6986	0904-6986-40	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6986-40)
GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	209215	ANDA	Safeway	21130-206	21130-206-58	2 BLISTER PACK in 1 CARTON (21130-206-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG
Approval Date:	Sep 6, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.2GM
Approval Date:	Sep 6, 2017	TE:		RLD:	No

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