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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 214980

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NDA 214980 describes OBETICHOLIC ACID, which is a drug marketed by Apotex, Lupin Ltd, and MSN, and is included in three NDAs. Additional details are available on the OBETICHOLIC ACID profile page.

The generic ingredient in OBETICHOLIC ACID is obeticholic acid. There is one drug master file entry for this compound. Additional details are available on the obeticholic acid profile page.

Summary for 214980

Tradename:	OBETICHOLIC ACID
Applicant:	Lupin Ltd
Ingredient:	obeticholic acid
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 30, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 30, 2023	TE:		RLD:	No

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