Details for New Drug Application (NDA): 209652
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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 209652
Tradename: | OXCARBAZEPINE |
Applicant: | Bionpharma |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209652
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 209652
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 209652 | ANDA | Bionpharma Inc. | 69452-125 | 69452-125-50 | 1 BOTTLE, GLASS in 1 CARTON (69452-125-50) / 250 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
Approval Date: | Nov 4, 2022 | TE: | AB | RLD: | No |
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