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Last Updated: November 21, 2024

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.
Summary for 216099
Tradename:PHYRAGO
Applicant:Nanocopoeia
Ingredient:dasatinib
Patents:3
Pharmacology for NDA: 216099
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:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 5, 2023TE: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 UpPatent Expiration:Jan 22, 2041Product 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 UpPatent Expiration:Jan 22, 2041Product 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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