Generated: December 16, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022006
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, 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
||National Drug Code
||Lundbeck Pharmaceuticals LLC
||50 PACKET in 1 CARTON (67386-211-65) > 10 mL in 1 PACKET
|Complete Access Available with Subscription
Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||FOR SOLUTION;ORAL||Strength||500MG/PACKET|
|Approval Date:||Aug 21, 2009||TE:||AA||RLD:||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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