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Serving 500+ biopharmaceutical companies globally:

Citi
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AstraZeneca
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Generated: August 19, 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 two 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 NDA: 022006

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 500+ biopharmaceutical companies globally:

US Department of Justice
Merck
Fuji
Federal Trade Commission
Teva
Dow
Chinese Patent Office
US Army
Queensland Health
Julphar

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