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. 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 020623

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

Pharmacology for NDA: 020623

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 020623

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANZEMET	dolasetron mesylate	TABLET;ORAL	020623	NDA	Validus Pharmaceuticals LLC	30698-220	30698-220-10	10 TABLET, FILM COATED in 1 BOTTLE (30698-220-10)

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

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