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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 021285


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NDA 021285 describes TRILEPTAL, which is a drug marketed by Novartis and is included in two NDAs. It is available from two suppliers. Additional details are available on the TRILEPTAL profile page.

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 021285
Tradename:TRILEPTAL
Applicant:Novartis
Ingredient:oxcarbazepine
Patents:0
Pharmacology for NDA: 021285
Suppliers and Packaging for NDA: 021285
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285 NDA Novartis Pharmaceuticals Corporation 0078-0357 0078-0357-52 250 mL in 1 BOTTLE (0078-0357-52)
TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285 NDA AUTHORIZED GENERIC Sandoz Inc 0781-6270 0781-6270-43 250 mL in 1 BOTTLE (0781-6270-43)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:May 25, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021285

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 ⤷  Sign Up ⤷  Sign Up
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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