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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211227

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NDA 211227 describes ESLICARBAZEPINE ACETATE, which is a drug marketed by Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, and Torrent, and is included in six NDAs. It is available from one supplier. Additional details are available on the ESLICARBAZEPINE ACETATE profile page.

The generic ingredient in ESLICARBAZEPINE ACETATE is eslicarbazepine acetate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.

Summary for 211227

Tradename:	ESLICARBAZEPINE ACETATE
Applicant:	Torrent
Ingredient:	eslicarbazepine acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Feb 27, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Feb 27, 2024	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Feb 27, 2024	TE:		RLD:	No

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