FDA Tentative Approval for YUTREPIA issued to Liquidia Technologies, Inc.
$LQDA
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 213005
Company: Liquidia Technologies, Inc.
Company: Liquidia Technologies, Inc.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| YUTREPIA | TREPROSTINIL | UNKNOWN | UNKNOWN | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/04/2021 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213005Orig1s000TAltr.pdf |