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The generic ingredient in QUTENZA is capsaicin. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the capsaicin profile page.
Generic Entry Opportunity Date for 022395
*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.
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
|Approval Date:||Nov 16, 2009||TE:||RLD:||Yes|
|Patent:||Start Trial||Patent Expiration:||Jun 4, 2021||Product Flag?||Y||Substance Flag?||Delist Request?|
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