Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216099
Company: NANOCOPOEIA
Company: NANOCOPOEIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHYRAGO | DASATINIB | 20MG | TABLET;ORAL | Prescription | None | Yes | No |
PHYRAGO | DASATINIB | 50MG | TABLET;ORAL | Prescription | None | Yes | No |
PHYRAGO | DASATINIB | 70MG | TABLET;ORAL | Prescription | None | Yes | No |
PHYRAGO | DASATINIB | 80MG | TABLET;ORAL | Prescription | None | Yes | No |
PHYRAGO | DASATINIB | 100MG | TABLET;ORAL | Prescription | None | Yes | Yes |
PHYRAGO | DASATINIB | 140MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/05/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216099s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216099Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/05/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216099s000lbl.pdf |