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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214350

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NDA 214350 describes DASATINIB, which is a drug marketed by Alembic, Apotex, Biocon Pharma, Dr Reddys, Eugia Pharma, Lupin, Teva Pharms Usa, and Zydus Pharms, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the DASATINIB profile page.

The generic ingredient in DASATINIB is dasatinib. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

Summary for 214350

Tradename:	DASATINIB
Applicant:	Lupin
Ingredient:	dasatinib
Patents:	0

Medical Subject Heading (MeSH) Categories for 214350

Antineoplastic Agents
Protein Kinase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Aug 25, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 25, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	70MG
Approval Date:	Aug 25, 2025	TE:	AB	RLD:	No

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