Last Updated: October 1, 2026

Details for New Drug Application (NDA): 216015

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NDA 216015 describes MIDOSTAURIN, which is a drug marketed by Dr Reddys, Lupin, and Teva Pharms, and is included in three NDAs. Additional details are available on the MIDOSTAURIN profile page.

The generic ingredient in MIDOSTAURIN is midostaurin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the midostaurin profile page.

Summary for 216015

Tradename:	MIDOSTAURIN
Applicant:	Lupin
Ingredient:	midostaurin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	May 10, 2024	TE:	AB	RLD:	No

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