Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208325
Company: KAI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARSABIV ETELCALCETIDE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
PARSABIV ETELCALCETIDE 5MG/ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
PARSABIV ETELCALCETIDE 10MG/2ML (5MG/ML) SOLUTION;INTRAVENOUS 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
02/07/2017 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208325Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208325Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2018 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208325s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208325Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208325s001lbl.pdf
02/07/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208325Orig1s000Lbledt.pdf

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