U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209988
Company: SCPHARMACEUTICALS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROSCIX FUROSEMIDE 80MG/10ML (8MG/ML) SOLUTION;SUBCUTANEOUS 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
10/07/2022 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209988Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209988Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/209988Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2024 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209988s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209988Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/09/2024 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209988s001lbl.pdf
10/07/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209988Orig1s000Correctedlbl.pdf
Back to Top