Details for New Drug Application (NDA): 217782
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The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 217782
Tradename: | OXCARBAZEPINE |
Applicant: | Medley Pharms |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217782
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 217782
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 217782 | ANDA | Medley Pharmaceuticals Limited | 42934-401 | 42934-401-11 | 250 mL in 1 BOTTLE, GLASS (42934-401-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
Approval Date: | Feb 14, 2024 | TE: | AB | RLD: | No |
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