Details for New Drug Application (NDA): 078069
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The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 078069
Tradename: | OXCARBAZEPINE |
Applicant: | Breckenridge Pharm |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Pharmacology for NDA: 078069
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078069
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 078069 | ANDA | Major Pharmaceuticals | 0904-7262 | 0904-7262-61 | 100 BLISTER PACK in 1 CARTON (0904-7262-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 078069 | ANDA | Major Pharmaceuticals | 0904-7263 | 0904-7263-61 | 100 BLISTER PACK in 1 CARTON (0904-7263-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jan 11, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jan 11, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Jan 11, 2008 | TE: | AB | RLD: | No |
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