Details for New Drug Application (NDA): 020763

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NDA 020763 describes AMERGE, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. Additional details are available on the AMERGE profile page.

The generic ingredient in AMERGE is naratriptan hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.

Summary for 020763

Tradename:	AMERGE
Applicant:	Glaxosmithkline Llc
Ingredient:	naratriptan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 10, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 10, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020763

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	AMERGE	naratriptan hydrochloride	TABLET;ORAL	020763-002	Feb 10, 1998	4,997,841	⤷ Subscribe
Glaxosmithkline Llc	AMERGE	naratriptan hydrochloride	TABLET;ORAL	020763-001	Feb 10, 1998	4,997,841	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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