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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216547

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NDA 216547 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 216547

Tradename:	DASATINIB
Applicant:	Eugia Pharma
Ingredient:	dasatinib
Patents:	0

Pharmacology for NDA: 216547

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for 216547

Antineoplastic Agents
Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 216547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DASATINIB	dasatinib	TABLET;ORAL	216547	ANDA	Aurobindo Pharma Limited	59651-542	59651-542-15	1 BLISTER PACK in 1 CARTON (59651-542-15) / 15 TABLET in 1 BLISTER PACK
DASATINIB	dasatinib	TABLET;ORAL	216547	ANDA	Aurobindo Pharma Limited	59651-542	59651-542-60	60 TABLET in 1 BOTTLE (59651-542-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Apr 22, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 22, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	70MG
Approval Date:	Apr 22, 2025	TE:	AB	RLD:	No

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