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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Teva
Queensland Health
Chubb
Boehringer Ingelheim
UBS
AstraZeneca
Farmers Insurance
US Department of Justice
Cipla

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021348

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NDA 021348 describes ZAVESCA, which is a drug marketed by Actelion Pharms Ltd 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. Two suppliers are listed for this compound. Additional details are available on the miglustat profile page.
Summary for 021348
Tradename:ZAVESCA
Applicant:Actelion Pharms Ltd
Ingredient:miglustat
Patents:0
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details
Pharmacology for NDA: 021348
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:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 31, 2003TE:RLD:Yes

Expired US Patents for NDA 021348

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms Ltd ZAVESCA miglustat CAPSULE;ORAL 021348-001 Jul 31, 2003 ➤ Subscribe ➤ Subscribe
Actelion Pharms Ltd ZAVESCA miglustat CAPSULE;ORAL 021348-001 Jul 31, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Deloitte
Cerilliant
Fish and Richardson
Dow
Baxter
Covington
Medtronic
QuintilesIMS
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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