Details for New Drug Application (NDA): 021585

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NDA 021585 describes MUCINEX D, which is a drug marketed by Rb Hlth and is included in two NDAs. It is available from four suppliers. Additional details are available on the MUCINEX D profile page.

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

Summary for 021585

Tradename:	MUCINEX D
Applicant:	Rb Hlth
Ingredient:	guaifenesin; pseudoephedrine hydrochloride
Patents:	0

Pharmacology for NDA: 021585

Mechanism of Action	Adrenergic alpha-Agonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Suppliers and Packaging for NDA: 021585

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585	NDA	WALGREEN COMPANY	0363-0077	0363-0077-18	1 BLISTER PACK in 1 CARTON (0363-0077-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585	NDA	WALGREEN COMPANY	0363-0077	0363-0077-36	2 BLISTER PACK in 1 CARTON (0363-0077-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG;60MG
Approval Date:	Jun 22, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.2GM;120MG
Approval Date:	Jun 22, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021585

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-002	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585-001	Jun 22, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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