Details for New Drug Application (NDA): 021348

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NDA 021348 describes ZAVESCA, which is a drug marketed by Actelion and is included in one NDA. It is available from two suppliers. Additional details are available on the ZAVESCA profile page.

The generic ingredient in ZAVESCA is miglustat. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the miglustat profile page.

Summary for 021348

Tradename:	ZAVESCA
Applicant:	Actelion
Ingredient:	miglustat
Patents:	0

Pharmacology for NDA: 021348

Mechanism of Action	Glucosylceramide Synthase Inhibitors

Suppliers and Packaging for NDA: 021348

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZAVESCA	miglustat	CAPSULE;ORAL	021348	NDA AUTHORIZED GENERIC	CoTherix, Inc.	10148-201	10148-201-90	6 BLISTER PACK in 1 CARTON (10148-201-90) / 15 CAPSULE in 1 BLISTER PACK (10148-201-15)
ZAVESCA	miglustat	CAPSULE;ORAL	021348	NDA	Actelion Pharmaceuticals US, Inc.	66215-201	66215-201-90	6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jul 31, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021348

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	⤷ Sign Up	⤷ Sign Up
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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