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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Dow
Chinese Patent Office
Healthtrust
Farmers Insurance
Citi
Mallinckrodt
Covington
Cerilliant

Generated: April 23, 2018

DrugPatentWatch Database Preview

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 two 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-three 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 021879
Tradename:NUEDEXTA
Applicant:Avanir Pharms
Ingredient:dextromethorphan hydrobromide; quinidine sulfate
Patents:2
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 N 64597-301-13
NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879 NDA Avanir Pharmaceuticals, Inc. 64597-301 N 64597-301-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG;10MG
Approval Date:Oct 29, 2010TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 13, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PSEUDOBULBAR AFFECT
Patent:➤ Try a Free TrialPatent Expiration:Jul 17, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PSEUDOBULBAR AFFECT

Expired US Patents for NDA 021879

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 ➤ Try a Free Trial ➤ Try a Free Trial
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Fuji
Moodys
Express Scripts
US Army
Accenture
Colorcon
Covington

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