Details for New Drug Application (NDA): 077794
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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 077794
Tradename: | OXCARBAZEPINE |
Applicant: | Sun Pharm Inds |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Pharmacology for NDA: 077794
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077794
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077794 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-183 | 62756-183-08 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-183-08) |
OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077794 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-183 | 62756-183-13 | 500 TABLET, FILM COATED in 1 BOTTLE (62756-183-13) |
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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