Last Updated: May 3, 2026

Details for New Drug Application (NDA): 020623

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NDA 020623 describes ANZEMET, which is a drug marketed by Validus Pharms and is included in two NDAs. 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. Additional details are available on the dolasetron mesylate profile page.

Summary for 020623

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 11, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 11, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020623

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997	⤷ Start Trial	⤷ Start Trial
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-001	Sep 11, 1997	⤷ Start Trial	⤷ Start Trial
Validus Pharms	ANZEMET	dolasetron mesylate	TABLET;ORAL	020623-002	Sep 11, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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