Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208447
Company: TESARO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEJULA NIRAPARIB TOSYLATE 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
03/27/2017 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208447Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208447_zejula_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/27/2017 ORIG-1 Approval Label (PDF) httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf

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