FDA — authorised 1 March 1976
- Application: ANDA083722
- Marketing authorisation holder: INTL MEDICATION
- Indication: Labeling
- Status: approved
🇺🇸 PHYTONADIONE in United States
FDA authorised PHYTONADIONE on 1 March 1976 · 2,747 US adverse-event reports
Marketing authorisations
FDA — authorised 20 February 2019
- Application: ANDA210189
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA — authorised 22 May 2019
- Application: ANDA207719
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 22 April 2022
- Application: ANDA214596
- Marketing authorisation holder: CIPLA
- Status: approved
FDA — authorised 28 July 2023
- Application: ANDA213329
- Marketing authorisation holder: SCIEGEN PHARMS
- Status: approved
FDA — authorised 12 October 2023
- Application: ANDA213336
- Marketing authorisation holder: AGNITIO
- Status: approved
FDA — authorised 3 January 2025
- Application: ANDA214966
- Marketing authorisation holder: CIPLA
- Status: approved
FDA — authorised 13 March 2026
- Application: ANDA216298
- Marketing authorisation holder: ORBICULAR
- 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: 2,747
Most-reported reactions
- Sepsis — 316 reports (11.5%)
- Nausea — 300 reports (10.92%)
- Vomiting — 294 reports (10.7%)
- Off Label Use — 289 reports (10.52%)
- Abdominal Distension — 275 reports (10.01%)
- Abdominal Pain — 262 reports (9.54%)
- Ascites — 260 reports (9.46%)
- General Physical Health Deterioration — 259 reports (9.43%)
- Hyponatraemia — 251 reports (9.14%)
- Multiple Organ Dysfunction Syndrome — 241 reports (8.77%)
PHYTONADIONE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is PHYTONADIONE approved in United States?
Yes. FDA authorised it on 1 March 1976; FDA authorised it on 20 February 2019; FDA authorised it on 22 May 2019.
Who is the marketing authorisation holder for PHYTONADIONE in United States?
INTL MEDICATION holds the US marketing authorisation.