Details for New Drug Application (NDA): 214896
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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 214896
Tradename: | PRIMIDONE |
Applicant: | Rubicon |
Ingredient: | primidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214896
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 214896
Suppliers and Packaging for NDA: 214896
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRIMIDONE | primidone | TABLET;ORAL | 214896 | ANDA | TruPharma LLC. | 52817-117 | 52817-117-10 | 100 TABLET in 1 BOTTLE (52817-117-10) |
PRIMIDONE | primidone | TABLET;ORAL | 214896 | ANDA | TruPharma LLC. | 52817-117 | 52817-117-30 | 30 TABLET in 1 BOTTLE (52817-117-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 28, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jun 28, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
Approval Date: | Dec 28, 2022 | TE: | RLD: | No |
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