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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213005
Company: LIQUIDIA TECH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YUTREPIA TREPROSTINIL SODIUM EQ 0.0265MG BASE/INH POWDER;INHALATION Prescription None Yes Yes
YUTREPIA TREPROSTINIL SODIUM EQ 0.053MG BASE/INH POWDER;INHALATION Prescription None Yes Yes
YUTREPIA TREPROSTINIL SODIUM EQ 0.0795MG BASE/INH POWDER;INHALATION Prescription None Yes Yes
YUTREPIA TREPROSTINIL SODIUM EQ 0.106MG BASE/INH POWDER;INHALATION 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
05/23/2025 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213005s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213005Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/23/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213005s000lbl.pdf
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