Details for New Drug Application (NDA): 083551
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The generic ingredient in PRIMIDONE is primidone. There are seven drug master file entries for this compound. Twenty-one 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 |
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 | 0591-5321-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01) |
PRIMIDONE | primidone | TABLET;ORAL | 083551 | ANDA | Actavis Pharma, Inc. | 0591-5321 | 0591-5321-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (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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