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. Thirty-five 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

Pharmacology for NDA: 020080

Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

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	0173-0478	0173-0478-00	2 SYRINGE in 1 CARTON (0173-0478-00) / .5 mL in 1 SYRINGE
IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080	NDA	GlaxoSmithKline LLC	0173-0479	0173-0479-00	2 SYRINGE in 1 PACKAGE (0173-0479-00) / .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1992	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date:	Feb 1, 2006	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:	Dec 23, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020080

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