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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Chinese Patent Office
Johnson and Johnson
Cantor Fitzgerald
Express Scripts

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022006

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NDA 022006 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 022006

Formulation / Manufacturing:see details

Pharmacology for NDA: 022006

Medical Subject Heading (MeSH) Categories for 022006

Suppliers and Packaging for NDA: 022006

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SABRIL vigabatrin FOR SOLUTION;ORAL 022006 NDA Lundbeck Pharmaceuticals LLC 67386-211 67386-211-65 50 PACKET in 1 CARTON (67386-211-65) > 10 mL in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength500MG/PACKET
Approval Date:Aug 21, 2009TE:AARLD:Yes
Regulatory Exclusivity Expiration:Oct 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Aug 21, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Apr 26, 2017
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
Fish and Richardson

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