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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Deloitte
Merck
Dow
Citi
Julphar
UBS
Moodys
Accenture

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020427

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NDA 020427 describes SABRIL, which is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the SABRIL profile page.

The generic ingredient in SABRIL is vigabatrin. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.
Summary for 020427
Tradename:SABRIL
Applicant:Lundbeck Pharms Llc
Ingredient:vigabatrin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020427
Medical Subject Heading (MeSH) Categories for 020427
Suppliers and Packaging for NDA: 020427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SABRIL vigabatrin TABLET;ORAL 020427 NDA Lundbeck Pharmaceuticals LLC 67386-111 67386-111-01 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 21, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 26, 2017
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Farmers Insurance
Harvard Business School
UBS
Baxter
US Army
McKinsey
AstraZeneca

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