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Last Updated: April 26, 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 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021285

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	May 25, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021285

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

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