Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208712
Company: CTI BIOPHARMA CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VONJO PACRITINIB CITRATE EQ 100MG BASE CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/2022 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208712Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/208712Orig1s000TOC.cfm

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