FDA — authorised 3 August 2020
- Application: NDA212593
- Marketing authorisation holder: AM REGENT
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 VASOPRESSIN in United States
FDA authorised VASOPRESSIN on 3 August 2020 · 4,839 US adverse-event reports
Marketing authorisations
FDA — authorised 18 July 2022
- Application: ANDA211857
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Status: approved
FDA — authorised 5 August 2022
- Application: ANDA212944
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 15 August 2022
- Application: ANDA214314
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 5 February 2024
- Application: NDA217569
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 May 2024
- Application: ANDA213988
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 11 July 2024
- Application: NDA217766
- Marketing authorisation holder: LONG GROVE PHARMS
- 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: 4,839
Most-reported reactions
- Drug Ineffective — 1,293 reports (26.72%)
- Hypotension — 534 reports (11.04%)
- Off Label Use — 519 reports (10.73%)
- Sepsis — 400 reports (8.27%)
- Cardiogenic Shock — 399 reports (8.25%)
- Multiple Organ Dysfunction Syndrome — 383 reports (7.91%)
- Condition Aggravated — 364 reports (7.52%)
- Toxicity To Various Agents — 321 reports (6.63%)
- Acute Kidney Injury — 317 reports (6.55%)
- Stress — 309 reports (6.39%)
VASOPRESSIN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is VASOPRESSIN approved in United States?
Yes. FDA authorised it on 3 August 2020; FDA authorised it on 18 July 2022; FDA authorised it on 5 August 2022.
Who is the marketing authorisation holder for VASOPRESSIN in United States?
AM REGENT holds the US marketing authorisation.