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Last Updated: April 25, 2024

Ingredient-type: Bile Acids and Salts

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Drugs of Ingredient-Type: Bile Acids and Salts

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750-002	Mar 17, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750-001	Mar 17, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	URSO 250	ursodiol	TABLET;ORAL	020675-001	Dec 10, 1997	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	URSO FORTE	ursodiol	TABLET;ORAL	020675-002	Jul 21, 2004	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eywa Pharma	URSODIOL	ursodiol	CAPSULE;ORAL	212452-001	Oct 30, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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