Details for New Drug Application (NDA): 202103
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NDA 202103 describes DASATINIB, which is a drug marketed by Apotex and is included in two NDAs. It is available from one supplier. 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
Pharmacology for NDA: 202103
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202103
Suppliers and Packaging for NDA: 202103
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | dasatinib | TABLET;ORAL | 202103 | ANDA | Apotex Corp. | 60505-3628 | 60505-3628-6 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-3628-6) |
| DASATINIB | dasatinib | TABLET;ORAL | 202103 | ANDA | Apotex Corp. | 60505-3629 | 60505-3629-6 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-3629-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 10, 2016 | 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 | 50MG | ||||
| Approval Date: | Jun 10, 2016 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 70MG | ||||
| Approval Date: | Jun 10, 2016 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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