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Details for New Drug Application (NDA): 022239

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NDA 022239 describes SUMAVEL DOSEPRO, which is a drug marketed by Endo Ventures Ltd and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug. Additional details are available on the SUMAVEL DOSEPRO profile page.

The generic ingredient in SUMAVEL DOSEPRO 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: 022239

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 022239

Suppliers and Packaging for NDA: 022239

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS 022239 NDA Zogenix, Inc. 43376-104 43376-104-01 1 SYRINGE, GLASS in 1 CARTON (43376-104-01) > .5 mL in 1 SYRINGE, GLASS
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS 022239 NDA Zogenix, Inc. 43376-104 43376-104-06 6 SYRINGE, GLASS in 1 CARTON (43376-104-06) > .5 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Jul 15, 2009TE:BXRLD:Yes
Patent:6,135,979Patent Expiration:Mar 21, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:6,251,091Patent Expiration:Dec 9, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,280,410Patent Expiration:Mar 27, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022239

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20095,891,086► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20096,280,410► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20095,957,886► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20096,251,091► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20096,174,304► Subscribe
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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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