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Serving leading biopharmaceutical companies globally:

Dow
Citi
Argus Health
Farmers Insurance
Julphar
Chinese Patent Office
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Colorcon

Generated: October 18, 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 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 leading biopharmaceutical companies globally:

McKesson
UBS
Accenture
Chinese Patent Office
Dow
Covington
Moodys
Daiichi Sankyo
AstraZeneca
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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