Details for New Drug Application (NDA): 201193
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The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 201193
Tradename: | OXCARBAZEPINE |
Applicant: | Hikma |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201193
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 201193
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 201193 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0199 | 0054-0199-59 | 250 mL in 1 BOTTLE (0054-0199-59) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
Approval Date: | Oct 3, 2012 | TE: | RLD: | No |
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