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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Queensland Health
Fuji
Harvard Business School
Mallinckrodt
Citi
Johnson and Johnson
QuintilesIMS
Julphar

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 009170

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NDA 009170 describes MYSOLINE, which is a drug marketed by Nuro Pharma and Valeant and is included in two NDAs. It is available from two suppliers. Additional details are available on the MYSOLINE profile page.

The generic ingredient in MYSOLINE is primidone. There are seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the primidone profile page.
Summary for 009170
Tradename:MYSOLINE
Applicant:Valeant
Ingredient:primidone
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 009170
Medical Subject Heading (MeSH) Categories for 009170
Suppliers and Packaging for NDA: 009170
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYSOLINE primidone TABLET;ORAL 009170 NDA Valeant Pharmaceuticals North America 66490-690 N 66490-690-10
MYSOLINE primidone TABLET;ORAL 009170 NDA Valeant Pharmaceuticals North America 66490-691 N 66490-691-10

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Dow
Colorcon
Medtronic
Accenture
QuintilesIMS
Cipla
Daiichi Sankyo
Boehringer Ingelheim

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