DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077802
The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are nineteen drug master file entries for this compound. Twenty-two 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 |
Therapeutic Class: | Anticonvulsants |
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 | REMEDYREPACK INC. | 24236-870 | N | 24236-870-02 |
OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077802 | ANDA | REMEDYREPACK INC. | 24236-885 | N | 24236-885-02 |
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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