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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 215921

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NDA 215921 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. One supplier is listed for this compound. Additional details are available on the midostaurin profile page.

Summary for 215921

Tradename:	MIDOSTAURIN
Applicant:	Dr Reddys
Ingredient:	midostaurin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jun 28, 2024	TE:	AB	RLD:	No

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