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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022395

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NDA 022395 describes QUTENZA, which is a drug marketed by Acorda and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the QUTENZA profile page.

The generic ingredient in QUTENZA is capsaicin. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the capsaicin profile page.

Summary for 022395

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 022395

Suppliers and Packaging for NDA: 022395

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUTENZA capsaicin PATCH;TOPICAL 022395 NDA Acorda Therapeutics, Inc. 10144-928 10144-928-01 1 KIT in 1 CARTON (10144-928-01) * 1 PATCH in 1 POUCH (10144-920-00) > 280 cm2 in 1 PATCH * 50 g in 1 TUBE
QUTENZA capsaicin PATCH;TOPICAL 022395 NDA Acorda Therapeutics, Inc. 10144-929 10144-929-01 1 KIT in 1 CARTON (10144-929-01) * 1 PATCH in 1 POUCH > 280 cm2 in 1 PATCH * 50 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength8%
Approval Date:Nov 16, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 16, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Jun 4, 2021Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Julphar
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