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Generated: April 30, 2017

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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 NDA: 022395

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022395

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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
Patent:6,239,180Patent Expiration:Nov 6, 2017Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Nov 16, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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