DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 083551
The generic ingredient in PRIMIDONE 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 083551
Tradename: | PRIMIDONE |
Applicant: | Watson Labs |
Ingredient: | primidone |
Patents: | 0 |
Therapeutic Class: | Anticonvulsants |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 083551
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 083551
Suppliers and Packaging for NDA: 083551
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRIMIDONE | primidone | TABLET;ORAL | 083551 | ANDA | Actavis Pharma, Inc. | 0591-5321 | N | 0591-5321-01 |
PRIMIDONE | primidone | TABLET;ORAL | 083551 | ANDA | Actavis Pharma, Inc. | 0591-5321 | N | 0591-5321-10 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No |
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