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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 twelve 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-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for NDA: 206099

Tradename:
ONZETRA XSAIL
Applicant:
Avanir Pharms
Ingredient:
sumatriptan succinate
Patents:12
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 11MG BASE
Approval Date:Jan 27, 2016TE:RLD:Yes
Patent:6,715,485Patent Expiration:Mar 3, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,047,202Patent Expiration:Jul 2, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:8,550,073Patent Expiration:Oct 22, 2029Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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