Details for New Drug Application (NDA): 040862
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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 040862
Tradename: | PRIMIDONE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | primidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040862
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 040862
Suppliers and Packaging for NDA: 040862
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRIMIDONE | primidone | TABLET;ORAL | 040862 | ANDA | Dr. Reddy's Laboratories Limited | 55111-476 | 55111-476-01 | 100 TABLET in 1 BOTTLE (55111-476-01) |
PRIMIDONE | primidone | TABLET;ORAL | 040862 | ANDA | Dr. Reddy's Laboratories Limited | 55111-476 | 55111-476-05 | 500 TABLET in 1 BOTTLE (55111-476-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Oct 3, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Oct 3, 2008 | TE: | RLD: | No |
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