FDA — authorised 17 April 2014
- Application: NDA204485
- Marketing authorisation holder: PH HEALTH
- Local brand name: VASOSTRICT
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 arginine vasopressin in United States
FDA authorised arginine vasopressin on 17 April 2014 · 19 US adverse-event reports
Marketing authorisations
FDA — authorised 3 August 2020
- Application: NDA212593
- Marketing authorisation holder: AM REGENT
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 December 2021
- Application: ANDA211538
- Marketing authorisation holder: EAGLE PHARMS
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 July 2022
- Application: ANDA211857
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 5 August 2022
- Application: ANDA212944
- Marketing authorisation holder: AMNEAL
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
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 29 September 2023
- Application: NDA217569
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 December 2023
- Application: ANDA217987
- Marketing authorisation holder: CIPLA
- 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
FDA — authorised 6 May 2026
- Application: ANDA212068
- Marketing authorisation holder: SANDOZ
- Local brand name: VASOPRESSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA212945
- Marketing authorisation holder: AMNEAL EU LTD
- Local brand name: VASOPRESSIN
- Indication: INJECTABLE — INJECTION
- 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: 19
Most-reported reactions
- Drug Ineffective — 5 reports (26.32%)
- Intestinal Ischaemia — 3 reports (15.79%)
- Off Label Use — 3 reports (15.79%)
- Cellulitis — 2 reports (10.53%)
- Adrenal Insufficiency — 1 report (5.26%)
- Apallic Syndrome — 1 report (5.26%)
- Bacteraemia — 1 report (5.26%)
- Blood Sodium Abnormal — 1 report (5.26%)
- Body Temperature Fluctuation — 1 report (5.26%)
- Brain Abscess — 1 report (5.26%)
arginine 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 arginine vasopressin approved in United States?
Yes. FDA authorised it on 17 April 2014; FDA authorised it on 3 August 2020; FDA authorised it on 15 December 2021.
Who is the marketing authorisation holder for arginine vasopressin in United States?
PH HEALTH holds the US marketing authorisation.