Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208114
Company: JAZZ PHARMS INC
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 |