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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211238

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NDA 211238 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 211238

Tradename:	ESLICARBAZEPINE ACETATE
Applicant:	Dr Reddys
Ingredient:	eslicarbazepine acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jun 29, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jun 29, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Jun 29, 2021	TE:	AB	RLD:	No

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