Details for New Drug Application (NDA): 021282

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NDA 021282 describes MUCINEX, which is a drug marketed by Rb Hlth and is included in three NDAs. It is available from nine suppliers. Additional details are available on the MUCINEX profile page.

The generic ingredient in MUCINEX 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 021282

Tradename:	MUCINEX
Applicant:	Rb Hlth
Ingredient:	guaifenesin
Patents:	0

Pharmacology for NDA: 021282

Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Medical Subject Heading (MeSH) Categories for 021282

Expectorants

Suppliers and Packaging for NDA: 021282

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282	NDA	ATLANTIC BIOLOGICAS CORP.	17856-0008	17856-0008-2	1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2)
MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282	NDA	A-S Medication Solutions	50090-0818	50090-0818-0	2 BLISTER PACK in 1 CARTON (50090-0818-0) / 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:	Jul 12, 2002	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1.2GM
Approval Date:	Dec 18, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021282

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-001	Jul 12, 2002	⤷ Sign Up	⤷ Sign Up
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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