Details for New Drug Application (NDA): 206099

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NDA 206099 describes ONZETRA XSAIL, which is a drug marketed by Currax 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. Thirty-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for 206099

Tradename:	ONZETRA XSAIL
Applicant:	Currax
Ingredient:	sumatriptan succinate
Patents:	16

Pharmacology for NDA: 206099

Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

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;NASAL	206099	NDA	Currax Pharmaceuticals LLC	42847-311	42847-311-08	8 POUCH in 1 CARTON (42847-311-08) / 2 CAPSULE in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;NASAL			Strength	EQ 11MG BASE
Approval Date:	Jan 27, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 20, 2034	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jul 30, 2029	Product 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:	⤷ Sign Up	Patent Expiration:	Jul 30, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF DELIVERING SUMATRIPTAN TO A NASAL CAVITY

Expired US Patents for NDA 206099

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	⤷ Sign Up	⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	⤷ Sign Up	⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	⤷ Sign Up	⤷ Sign Up
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099-001	Jan 27, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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