Details for New Drug Application (NDA): 020132

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NDA 020132 describes IMITREX, which is a drug marketed by Glaxosmithkline and is included in three NDAs. It is available from two suppliers. Additional details are available on the IMITREX profile page.

The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.

Summary for 020132

Tradename:	IMITREX
Applicant:	Glaxosmithkline
Ingredient:	sumatriptan succinate
Patents:	0

Pharmacology for NDA: 020132

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

Suppliers and Packaging for NDA: 020132

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IMITREX	sumatriptan succinate	TABLET;ORAL	020132	NDA	GlaxoSmithKline LLC	0173-0735	0173-0735-00	1 CARTON in 1 CARTON (0173-0735-00) / 1 BLISTER PACK in 1 CARTON / 9 TABLET, FILM COATED in 1 BLISTER PACK
IMITREX	sumatriptan succinate	TABLET;ORAL	020132	NDA	GlaxoSmithKline LLC	0173-0736	0173-0736-01	1 CARTON in 1 CARTON (0173-0736-01) / 1 BLISTER PACK in 1 CARTON / 9 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jun 1, 1995	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Jun 1, 1995	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jun 1, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020132

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	6,368,627*PED	⤷ Subscribe
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-001	Jun 1, 1995	6,020,001*PED	⤷ Subscribe
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-002	Jun 1, 1995	6,368,627*PED	⤷ Subscribe
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-003	Jun 1, 1995	6,020,001*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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