Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220482
Company: HAISCO
Company: HAISCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYPSEDO | CIPEPOFOL | 50MG/20ML (2.5MG/ML) | EMULSION;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 |
|---|---|---|---|---|---|---|
| 05/29/2026 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Federal Register Notice
Label (PDF) Letter (PDF) Review |
FR Notice on DEA Scheduling; Date of Approval – August 27, 2026 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note |
|---|---|---|---|---|
| 05/29/2026 | ORIG-1 | Approval | Label (PDF) |