Details for New Drug Application (NDA): 020624

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NDA 020624 describes ANZEMET, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the ANZEMET profile page.

The generic ingredient in ANZEMET is dolasetron mesylate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolasetron mesylate profile page.

Summary for 020624

Tradename:	ANZEMET
Applicant:	Validus Pharms
Ingredient:	dolasetron mesylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/5ML (20MG/ML)
Approval Date:	Sep 11, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	12.5MG/0.625ML (20MG/ML)
Approval Date:	Sep 11, 1997	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/25ML (20MG/ML)
Approval Date:	Dec 11, 2001	TE:		RLD:	No

Expired US Patents for NDA 020624

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-002	Sep 11, 1997	⤷ Sign Up	⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-003	Dec 11, 2001	⤷ Sign Up	⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	Sep 11, 1997	⤷ Sign Up	⤷ Sign Up
Validus Pharms	ANZEMET	dolasetron mesylate	INJECTABLE;INJECTION	020624-001	Sep 11, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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