Details for New Drug Application (NDA): 040866
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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 040866
Tradename: | PRIMIDONE |
Applicant: | Amneal Pharm |
Ingredient: | primidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040866
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 040866
Suppliers and Packaging for NDA: 040866
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRIMIDONE | primidone | TABLET;ORAL | 040866 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8206 | 0615-8206-39 | 30 TABLET in 1 BLISTER PACK (0615-8206-39) |
PRIMIDONE | primidone | TABLET;ORAL | 040866 | ANDA | AvKARE | 42291-509 | 42291-509-01 | 100 TABLET in 1 BOTTLE (42291-509-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Apr 23, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Apr 23, 2008 | TE: | AB | RLD: | No |
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