FDA — authorised 17 April 2014
- Application: NDA204485
- Marketing authorisation holder: PH HEALTH
- Local brand name: VASOSTRICT
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Vasopressins in United States
FDA authorised Vasopressins on 17 April 2014 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 15 August 2022
- Application: ANDA214314
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 May 2023
- Application: ANDA213206
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 9 February 2024
- Application: ANDA216963
- Marketing authorisation holder: GLAND
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 May 2024
- Application: ANDA213988
- Marketing authorisation holder: DR REDDYS
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 July 2024
- Application: NDA217766
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 May 2026
- Application: ANDA212069
- Marketing authorisation holder: SANDOZ
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA granted marketing authorisation to Sandoz's Vasopressin (VASOPRESSIN) for intravenous use on May 6, 2026. This approval was based on a standard application (ANDA212069). Vasopressin is a solution intended for intravenous administration. The approval allows Sandoz to market Vasopressin in the United States.
FDA — authorised 6 May 2026
- Application: ANDA212068
- Marketing authorisation holder: SANDOZ
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 10
Most-reported reactions
- Anorexia — 1 report (10%)
- Atrial Fibrillation — 1 report (10%)
- Blood Creatinine Increased — 1 report (10%)
- Candidiasis — 1 report (10%)
- Cardiac Failure — 1 report (10%)
- Cardiogenic Shock — 1 report (10%)
- Catheter Related Infection — 1 report (10%)
- Cystitis Noninfective — 1 report (10%)
- Dysgeusia — 1 report (10%)
- Fungus Stool Identified — 1 report (10%)
Vasopressins in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Vasopressins approved in United States?
Yes. FDA authorised it on 17 April 2014; FDA authorised it on 15 August 2022; FDA authorised it on 26 May 2023.
Who is the marketing authorisation holder for Vasopressins in United States?
PH HEALTH holds the US marketing authorisation.