Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210730
Company: TREVENA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLINVYK OLICERIDINE 1MG/ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
OLINVYK OLICERIDINE 2MG/2ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
OLINVYK OLICERIDINE 30MG/30ML (1MG/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
08/07/2020 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210730s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210730Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210730Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/07/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210730s000lbl.pdf

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