Details for New Drug Application (NDA): 216099
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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