FDA — authorised 28 June 1960
- Application: NDA012223
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: AQUAMEPHYTON
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Vitamin K1 in United States
FDA authorised Vitamin K1 on 28 June 1960 · 1,554 US adverse-event reports
Marketing authorisations
FDA — authorised 1 March 1976
- Application: ANDA083722
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 1983
- Application: ANDA087954
- Marketing authorisation holder: HOSPIRA
- Local brand name: VITAMIN K1
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 1983
- Application: ANDA087955
- Marketing authorisation holder: HOSPIRA
- Local brand name: VITAMIN K1
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 1983
- Application: ANDA087956
- Marketing authorisation holder: HOSPIRA
- Local brand name: VITAMIN K1
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 May 2018
- Application: ANDA209373
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: PHYTONADIONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 2019
- Application: ANDA210189
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: PHYTONADIONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2019
- Application: ANDA207719
- Marketing authorisation holder: DR REDDYS
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 April 2022
- Application: ANDA214596
- Marketing authorisation holder: CIPLA
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 April 2022
- Application: ANDA212424
- Marketing authorisation holder: CIPLA
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 2023
- Application: ANDA213329
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: PHYTONADIONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 October 2023
- Application: ANDA213336
- Marketing authorisation holder: AGNITIO
- Local brand name: PHYTONADIONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 2024
- Application: ANDA217386
- Marketing authorisation holder: GLAND
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 2024
- Application: ANDA212112
- Marketing authorisation holder: HIKMA
- Local brand name: PHYTONADIONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2025
- Application: ANDA214966
- Marketing authorisation holder: CIPLA
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 2025
- Application: ANDA219212
- Marketing authorisation holder: CAPLIN
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 September 2025
- Application: ANDA216444
- Marketing authorisation holder: ALEMBIC
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 November 2025
- Application: ANDA216601
- Marketing authorisation holder: AMNEAL
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 January 2026
- Application: ANDA215090
- Marketing authorisation holder: SUNNY
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 2026
- Application: ANDA220454
- Marketing authorisation holder: SINOTHERAPEUTICS INC
- Local brand name: PHYTONADIONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2026
- Application: ANDA216852
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 March 2026
- Application: ANDA216298
- Marketing authorisation holder: ORBICULAR
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA011745
- Marketing authorisation holder: ROCHE
- Local brand name: KONAKION
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA084060
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: PHYTONADIONE
- Indication: INJECTABLE — INJECTION
- 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: 19 April 2025 – 19 April 2026
- Total reports: 1,554
Most-reported reactions
- Off Label Use — 194 reports (12.48%)
- Nausea — 171 reports (11%)
- Vomiting — 158 reports (10.17%)
- Abdominal Distension — 154 reports (9.91%)
- Constipation — 149 reports (9.59%)
- Dyspnoea — 147 reports (9.46%)
- Sepsis — 147 reports (9.46%)
- Ascites — 146 reports (9.4%)
- Abdominal Pain — 144 reports (9.27%)
- Condition Aggravated — 144 reports (9.27%)
Vitamin K1 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Vitamin K1 approved in United States?
Yes. FDA authorised it on 28 June 1960; FDA authorised it on 1 March 1976; FDA authorised it on 25 July 1983.
Who is the marketing authorisation holder for Vitamin K1 in United States?
PAI HOLDINGS PHARM holds the US marketing authorisation.