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Generated: November 13, 2018

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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 one supplier. 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 six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the capsaicin profile page.
Summary for 022395
Tradename:QUTENZA
Applicant:Acorda
Ingredient:capsaicin
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022395
Generic Entry Date for 022395*:
Constraining patent/regulatory exclusivity:
Dosage:
PATCH;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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) * 50 g in 1 TUBE * 1 PATCH in 1 POUCH (10144-920-00) > 280 cm2 in 1 PATCH
QUTENZA capsaicin PATCH;TOPICAL 022395 NDA Acorda Therapeutics, Inc. 10144-929 10144-929-01 1 KIT in 1 CARTON (10144-929-01) * 50 g in 1 TUBE * 1 PATCH in 1 POUCH > 280 cm2 in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength8%
Approval Date:Nov 16, 2009TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 4, 2021Product Flag?YSubstance Flag?Delist Request?

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