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Generated: January 23, 2019

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Details for New Drug Application (NDA): 206099

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NDA 206099 describes ONZETRA XSAIL, which is a drug marketed by Avanir Pharms and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the ONZETRA XSAIL profile page.

The generic ingredient in ONZETRA XSAIL is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 206099
Tradename:ONZETRA XSAIL
Applicant:Avanir Pharms
Ingredient:sumatriptan succinate
Patents:16
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206099
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONZETRA XSAIL sumatriptan succinate POWDER;INHALATION 206099 NDA Avanir Pharmaceuticals, Inc. 64597-311 64597-311-08 1 KIT in 1 CARTON (64597-311-08) * 8 POUCH in 1 CARTON > 2 CAPSULE in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 11MG BASE
Approval Date:Jan 27, 2016TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 20, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jul 30, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE BY DELIVERING A POWDERED SUBSTANCE COMPRISING SUMATRIPTAN VIA A BREATH-POWERED DELIVERY DEVICE
Patent:➤ Try a Free TrialPatent Expiration:Jul 30, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF DELIVERING SUMATRIPTAN TO A NASAL CAVITY

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