Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208109
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS 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
11/21/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208109s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208109Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208109Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2018 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208109Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208109s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/06/2018 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208109Orig1s001lbl.pdf
11/21/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208109s000lbl.pdf

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