Details for New Drug Application (NDA): 040586
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The generic ingredient in PRIMIDONE 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 040586
Tradename: | PRIMIDONE |
Applicant: | Oxford Pharms |
Ingredient: | primidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040586
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 040586
Suppliers and Packaging for NDA: 040586
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRIMIDONE | primidone | TABLET;ORAL | 040586 | ANDA | Oxford Pharmaceuticals, LLC | 69584-684 | 69584-684-10 | 100 TABLET in 1 BOTTLE, PLASTIC (69584-684-10) |
PRIMIDONE | primidone | TABLET;ORAL | 040586 | ANDA | Oxford Pharmaceuticals, LLC | 69584-684 | 69584-684-50 | 500 TABLET in 1 BOTTLE, PLASTIC (69584-684-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Feb 24, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Feb 24, 2005 | TE: | AB | RLD: | No |
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