Details for New Drug Application (NDA): 218719
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NDA 218719 describes DASATINIB, which is a drug marketed by Apotex, Biocon Pharma, Dr Reddys, and Zydus Pharms, and is included in five NDAs. It is available from five 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. Eight suppliers are listed for this compound. 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. Eight suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
Summary for 218719
| Tradename: | DASATINIB |
| Applicant: | Zydus Pharms |
| Ingredient: | dasatinib |
| Patents: | 0 |
Pharmacology for NDA: 218719
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218719
Suppliers and Packaging for NDA: 218719
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | dasatinib | TABLET;ORAL | 218719 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1741 | 70710-1741-6 | 60 TABLET in 1 BOTTLE (70710-1741-6) |
| DASATINIB | dasatinib | TABLET;ORAL | 218719 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1742 | 70710-1742-6 | 60 TABLET in 1 BOTTLE (70710-1742-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Mar 3, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 3, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 70MG | ||||
| Approval Date: | Mar 3, 2025 | TE: | AB | RLD: | No | ||||
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