Details for New Drug Application (NDA): 218366
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NDA 218366 describes PRIMIDONE, which is a drug marketed by Amneal Pharm, Anda Repository, Carnegie, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, Rubicon, and Watson Labs, and is included in eleven NDAs. It is available from twenty suppliers. Additional details are available on the PRIMIDONE profile page.
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.
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.
Pharmacology for NDA: 218366
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 218366
Suppliers and Packaging for NDA: 218366
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRIMIDONE | primidone | TABLET;ORAL | 218366 | ANDA | Carnegie Pharmaceuticals LLC | 80005-117 | 80005-117-11 | 100 TABLET in 1 BOTTLE (80005-117-11) |
| PRIMIDONE | primidone | TABLET;ORAL | 218366 | ANDA | Carnegie Pharmaceuticals LLC | 80005-117 | 80005-117-14 | 500 TABLET in 1 BOTTLE (80005-117-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 23, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jan 23, 2024 | TE: | AB | RLD: | No | ||||
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