Details for New Drug Application (NDA): 021014
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The generic ingredient in TRILEPTAL is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 021014
Tradename: | TRILEPTAL |
Applicant: | Novartis |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Pharmacology for NDA: 021014
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 021014
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014 | NDA | Novartis Pharmaceuticals Corporation | 0078-0337 | 0078-0337-05 | 100 TABLET, FILM COATED in 1 BOTTLE (0078-0337-05) |
TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014 | NDA | Novartis Pharmaceuticals Corporation | 0078-0337 | 0078-0337-06 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0337-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0337-61) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jan 14, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jan 14, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Jan 14, 2000 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021014
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-001 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-003 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-002 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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