Details for New Drug Application (NDA): 210453

NDA 210453 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-six 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 210453

Tradename:	GUAIFENESIN
Applicant:	Aurobindo Pharma
Ingredient:	guaifenesin
Patents:	0

Pharmacology for NDA: 210453

Physiological Effect

Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Medical Subject Heading (MeSH) Categories for 210453

Expectorants

Suppliers and Packaging for NDA: 210453

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	210453	ANDA	WALGREEN CO.	0363-0028	0363-0028-96	1 BLISTER PACK in 1 CARTON (0363-0028-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	210453	ANDA	WALGREEN CO.	0363-0028	0363-0028-97	2 BLISTER PACK in 1 CARTON (0363-0028-97) / 20 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:	Oct 21, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.2GM
Approval Date:	Oct 21, 2019	TE:		RLD:	No

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