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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 021014

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NDA 021014 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 021014

Tradename:	TRILEPTAL
Applicant:	Novartis
Ingredient:	oxcarbazepine
Patents:	0
Formulation / Manufacturing:	see details

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-003	Jan 14, 2000	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-001	Jan 14, 2000	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-002	Jan 14, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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