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. One supplier is listed for this compound. Additional details are available on the dasatinib profile page.
Summary for 216099
Tradename: | PHYRAGO |
Applicant: | Nanocopoeia |
Ingredient: | dasatinib |
Patents: | 3 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 216099
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 5, 2023 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT |
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