Details for New Drug Application (NDA): 021879

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NDA 021879 describes NUEDEXTA, which is a drug marketed by Avanir Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the NUEDEXTA profile page.

The generic ingredient in NUEDEXTA is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

Summary for 021879

Tradename:	NUEDEXTA
Applicant:	Avanir Pharms
Ingredient:	dextromethorphan hydrobromide; quinidine sulfate
Patents:	1

Pharmacology for NDA: 021879

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

Suppliers and Packaging for NDA: 021879

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879	NDA	Otsuka America Pharmaceutical, Inc	59148-053	59148-053-16	60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)
NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879	NDA	Otsuka America Pharmaceutical, Inc	59148-053	59148-053-98	4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG;10MG
Approval Date:	Oct 29, 2010	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 13, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PSEUDOBULBAR AFFECT

Expired US Patents for NDA 021879

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	⤷ Sign Up	⤷ Sign Up
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	⤷ Sign Up	⤷ Sign Up
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	⤷ Sign Up	⤷ Sign Up
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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