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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211247

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NDA 211247 describes ESLICARBAZEPINE ACETATE, which is a drug marketed by Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Sph Zhongxi Pharm, and Torrent, and is included in eight NDAs. It is available from seven suppliers. 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. Eight suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.

Summary for 211247

Tradename:	ESLICARBAZEPINE ACETATE
Applicant:	Sph Zhongxi Pharm
Ingredient:	eslicarbazepine acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Nov 3, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Nov 3, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Nov 3, 2025	TE:	AB	RLD:	No

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