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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018719

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NDA 018719 describes MODRASTANE, which is a drug marketed by Bioenvision and is included in one NDA. Additional details are available on the MODRASTANE profile page.

The generic ingredient in MODRASTANE is trilostane. There are two drug master file entries for this compound. Additional details are available on the trilostane profile page.

Summary for 018719

Tradename:	MODRASTANE
Applicant:	Bioenvision
Ingredient:	trilostane
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	60MG
Approval Date:	Dec 31, 1984	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Dec 31, 1984	TE:		RLD:	No

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