Details for New Drug Application (NDA): 021620

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NDA 021620 describes MUCINEX DM, which is a drug marketed by Rb Hlth and is included in one NDA. It is available from eleven suppliers. Additional details are available on the MUCINEX DM profile page.

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

Summary for 021620

Tradename:	MUCINEX DM
Applicant:	Rb Hlth
Ingredient:	dextromethorphan hydrobromide; guaifenesin
Patents:	0

Pharmacology for NDA: 021620

Mechanism of Action	Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

Suppliers and Packaging for NDA: 021620

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620	NDA	Rite-Aid	11822-7156	11822-7156-0	1 BLISTER PACK in 1 CARTON (11822-7156-0) > 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620	NDA	Rite-Aid	11822-7156	11822-7156-9	1 BLISTER PACK in 1 CARTON (11822-7156-9) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG;1.2GM
Approval Date:	Apr 29, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG;600MG
Approval Date:	Apr 29, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021620

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004	See Plans and Pricing	See Plans and Pricing
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-002	Apr 29, 2004	See Plans and Pricing	See Plans and Pricing
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004	See Plans and Pricing	See Plans and Pricing
Rb Hlth	MUCINEX DM	dextromethorphan hydrobromide; guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021620-001	Apr 29, 2004	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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