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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203180


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NDA 203180 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 203180
Tradename:DASATINIB
Applicant:Apotex
Ingredient:dasatinib
Patents:0
Pharmacology for NDA: 203180
Mechanism of ActionCytochrome P450 3A4 Inhibitors
Protein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 203180
Antineoplastic Agents
Protein Kinase Inhibitors
Suppliers and Packaging for NDA: 203180
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DASATINIB dasatinib TABLET;ORAL 203180 ANDA Apotex Corp. 60505-3816 60505-3816-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3)
DASATINIB dasatinib TABLET;ORAL 203180 ANDA Apotex Corp. 60505-3817 60505-3817-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3817-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Nov 23, 2021TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 2, 2025
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength140MG
Approval Date:Nov 23, 2021TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 2, 2025
Regulatory Exclusivity Use:PATENT CHALLENGE

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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