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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 one supplier. There are three patents 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-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

Summary for NDA: 021879

Tradename:
NUEDEXTA
Applicant:
Avanir Pharms
Ingredient:
dextromethorphan hydrobromide; quinidine sulfate
Patents:3
Formulation / Manufacturing:see details

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 Avanir Pharmaceuticals, Inc. 64597-301 64597-301-13 1 BOTTLE in 1 CARTON (64597-301-13) > 13 CAPSULE, GELATIN COATED in 1 BOTTLE
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL 021879 NDA Avanir Pharmaceuticals, Inc. 64597-301 64597-301-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;10MG
Approval Date:Oct 29, 2010TE:RLD:Yes
Patent:RE38115Patent Expiration:Jan 26, 2016Product Flag?YSubstance Flag?Delist Request?Y
Patent:7,659,282Patent Expiration:Aug 13, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PSEUDOBULBAR AFFECT
Patent:8,227,484Patent Expiration:Jul 17, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PSEUDOBULBAR AFFECT

Expired Orange Book Patents for NDA: 021879

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 20105,166,207► subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RE38115► subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 20105,206,248► subscribe
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