Details for New Drug Application (NDA): 202961
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The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 202961
Tradename: | OXCARBAZEPINE |
Applicant: | Amneal Pharms |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202961
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 202961
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 202961 | ANDA | AvPAK | 50268-649 | 50268-649-30 | 30 CUP, UNIT-DOSE in 1 TRAY (50268-649-30) / 5 mL in 1 CUP, UNIT-DOSE (50268-649-05) |
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 202961 | ANDA | Amneal Pharmaceuticals LLC | 65162-649 | 65162-649-48 | 10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
Approval Date: | Sep 17, 2012 | TE: | AB | RLD: | No |
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