FDA Approval for FUROSCIX issued to SCPHARMACEUTICALS INC
$SCPH
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 209988
Company: SCPHARMACEUTICALS INC
Company: SCPHARMACEUTICALS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUROSCIX | FUROSEMIDE | 80MG/10ML | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 10/07/2022 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209988Orig1s000ltr.pdf |