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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208114
Company: JAZZ PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEFITELIO DEFIBROTIDE SODIUM 200MG/2.5ML (80MG/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
03/30/2016 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208114Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208114Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208114Orig1s000SumR.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/30/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114Orig1s000Lbl.pdf
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