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Generated: April 24, 2019

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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 two suppliers. Additional details are available on the IMITREX STATDOSE profile page.

The generic ingredient in IMITREX STATDOSE is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 020080
Tradename:IMITREX STATDOSE
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

Profile 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

Profile 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

Profile 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 US Patents for NDA 020080

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-002 Feb 1, 2006 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-003 Dec 23, 1996 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-003 Dec 23, 1996 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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