Details for New Drug Application (NDA): 077802
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The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 077802
Tradename: | OXCARBAZEPINE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077802
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077802
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077802 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-2973 | 68071-2973-9 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-2973-9) |
OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077802 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-137 | 68462-137-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-137-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Oct 9, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Oct 9, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Oct 9, 2007 | TE: | AB | RLD: | No |
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