Details for New Drug Application (NDA): 021001

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NDA 021001 describes AXERT, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the AXERT profile page.

The generic ingredient in AXERT is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.

Summary for 021001

Tradename:	AXERT
Applicant:	Janssen Pharms
Ingredient:	almotriptan malate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 7, 2001	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 7, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021001

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-001	May 7, 2001	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-002	May 7, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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