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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216261

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NDA 216261 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 216261

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

Pharmacology for NDA: 216261

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for 216261

Antineoplastic Agents
Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 216261

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DASATINIB	dasatinib	TABLET;ORAL	216261	ANDA	Alembic Pharmaceuticals Limited	46708-684	46708-684-60	60 TABLET, FILM COATED in 1 BOTTLE (46708-684-60)
DASATINIB	dasatinib	TABLET;ORAL	216261	ANDA	Alembic Pharmaceuticals Limited	46708-685	46708-685-60	60 TABLET, FILM COATED in 1 BOTTLE (46708-685-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Nov 6, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 6, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	70MG
Approval Date:	Nov 6, 2025	TE:	AB	RLD:	No

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