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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
QuintilesIMS
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Argus Health
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Baxter

Generated: June 27, 2017

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 one supplier. 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 NDA: 009170

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 66490-690-10 100 TABLET in 1 BOTTLE (66490-690-10)
MYSOLINE
primidone
TABLET;ORAL 009170 NDA Valeant Pharmaceuticals North America 66490-691 66490-691-10 100 TABLET in 1 BOTTLE (66490-691-10)

Summary for product number 002

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

Summary 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 500+ biopharmaceutical companies globally:

McKesson
Cerilliant
US Department of Justice
Chubb
Novartis
Fuji
Farmers Insurance
Teva
Citi
Boehringer Ingelheim

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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