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Details for New Drug Application (NDA): 020080

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NDA 020080 describes IMITREX STATDOSE, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. Additional details are available on the IMITREX STATDOSE profile page.

The generic ingredient in IMITREX STATDOSE 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: 020080

Tradename:
IMITREX
Applicant:
Glaxosmithkline
Ingredient:
sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020080

Suppliers and Packaging for NDA: 020080

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMITREX
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS 020080 NDA GlaxoSmithKline LLC 0173-0449 0173-0449-02 5 VIAL in 1 CARTON (0173-0449-02) > .5 mL in 1 VIAL
IMITREX
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS 020080 NDA GlaxoSmithKline LLC 0173-0478 0173-0478-00 2 SYRINGE in 1 CARTON (0173-0478-00) > .5 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Dec 28, 1992TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date:Feb 1, 2006TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Dec 23, 1996TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020080

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
IMITREX
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-001Dec 28, 19924,816,470*PED► subscribe
Glaxosmithkline
IMITREX STATDOSE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-003Dec 23, 19965,037,845*PED► subscribe
Glaxosmithkline
IMITREX STATDOSE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-003Dec 23, 19964,816,470*PED► subscribe
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