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Last Updated: April 22, 2024

Details for New Drug Application (NDA): 009170

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NDA 009170 describes MYSOLINE, which is a drug marketed by Fhta 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. Twenty suppliers are listed for this compound. Additional details are available on the primidone profile page.
Summary for 009170
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 Bausch Health US, LLC 66490-690 66490-690-10 100 TABLET in 1 BOTTLE (66490-690-10)
MYSOLINE primidone TABLET;ORAL 009170 NDA Bausch Health US, LLC 66490-691 66490-691-10 100 TABLET in 1 BOTTLE (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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