Details for New Drug Application (NDA): 216099
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NDA 216099 describes PHYRAGO, which is a drug marketed by Nanocopoeia and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the PHYRAGO profile page.
The generic ingredient in PHYRAGO 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 PHYRAGO 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.
Summary for 216099
| Tradename: | PHYRAGO |
| Applicant: | Nanocopoeia |
| Ingredient: | dasatinib |
| Patents: | 3 |
Pharmacology for NDA: 216099
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 216099
Suppliers and Packaging for NDA: 216099
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHYRAGO | dasatinib | TABLET;ORAL | 216099 | NDA | Nanocopoeia | 83858-101 | 83858-101-60 | 60 TABLET in 1 BOTTLE (83858-101-60) |
| PHYRAGO | dasatinib | TABLET;ORAL | 216099 | NDA | Nanocopoeia | 83858-102 | 83858-102-60 | 60 TABLET in 1 BOTTLE (83858-102-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 5, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 5, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS | ||||||||
| Patent: | 11,202,778 | Patent Expiration: | Jan 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT | ||||||||
| Patent: | 11,202,778 | Patent Expiration: | Jan 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT | ||||||||
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