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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
Applicant:Lundbeck Pharms Llc
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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Farmers Insurance
Harvard Business School
US Army

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