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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 020626

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NDA 020626 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. Eight suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.

Summary for 020626

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

Pharmacology for NDA: 020626

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

Medical Subject Heading (MeSH) Categories for 020626

Serotonin 5-HT1 Receptor Agonists
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 020626

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IMITREX	sumatriptan	SPRAY;NASAL	020626	NDA	GlaxoSmithKline LLC	0173-0523	0173-0523-00	6 CONTAINER in 1 BOX (0173-0523-00) / 1 SPRAY in 1 CONTAINER
IMITREX	sumatriptan	SPRAY;NASAL	020626	NDA	GlaxoSmithKline LLC	0173-0524	0173-0524-00	6 CONTAINER in 1 BOX (0173-0524-00) / 1 SPRAY in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	5MG/SPRAY
Approval Date:	Aug 26, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY;NASAL			Strength	10MG/SPRAY
Approval Date:	Aug 26, 1997	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;NASAL			Strength	20MG/SPRAY
Approval Date:	Aug 26, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020626

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-002	Aug 26, 1997	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-001	Aug 26, 1997	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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