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. Nineteen suppliers are listed for this compound. Additional details are available on the primidone profile page.
The generic ingredient in MYSOLINE is primidone. There are seven drug master file entries for this compound. Nineteen 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 009170
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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