Details for New Drug Application (NDA): 203180
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The generic ingredient in DASATINIB is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
Pharmacology for NDA: 203180
Mechanism of Action | Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203180
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: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Nov 23, 2021 | TE: | AB | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Mar 2, 2025 | ||||||||
Regulatory Exclusivity Use: | PATENT CHALLENGE |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 140MG | ||||
Approval Date: | Nov 23, 2021 | TE: | AB | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Mar 2, 2025 | ||||||||
Regulatory Exclusivity Use: | PATENT CHALLENGE |
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