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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 fifteen 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:
SUMAVEL DOSEPRO
Applicant:
Endo Ventures Ltd
Ingredient:
sumatriptan succinate
Patents:15
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:5,957,886Patent Expiration:Mar 8, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,135,979Patent Expiration:Mar 21, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:6,174,304Patent Expiration:Dec 13, 2015Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022239

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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, 20096,681,810► subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20096,174,304► subscribe
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