FDA — authorised 4 March 1987
- Application: ANDA071104
- Marketing authorisation holder: XANODYNE PHARM
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Folinic Acid in United States
FDA authorised Folinic Acid on 4 March 1987 · 9,133 US adverse-event reports
Marketing authorisations
FDA — authorised 14 September 1987
- Application: ANDA089384
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 March 1988
- Application: ANDA089717
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 1993
- Application: ANDA072736
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 1993
- Application: ANDA072733
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 1993
- Application: ANDA072734
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 1993
- Application: ANDA072735
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 1993
- Application: ANDA081277
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 September 1993
- Application: ANDA081278
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 June 1994
- Application: ANDA081224
- Marketing authorisation holder: ELKINS SINN
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 May 1995
- Application: ANDA040056
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 August 1997
- Application: ANDA074544
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1999
- Application: ANDA040258
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1999
- Application: ANDA040286
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 June 1999
- Application: ANDA040332
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 20 April 2000
- Application: ANDA040335
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 2000
- Application: ANDA040347
- Marketing authorisation holder: HIKMA
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 31 January 2001
- Application: ANDA040338
- Marketing authorisation holder: AM REGENT
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 September 2012
- Application: ANDA200855
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 September 2012
- Application: ANDA200753
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: LEUCOVORIN CALCIUM PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 March 2018
- Application: ANDA207241
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 27 July 2018
- Application: ANDA207226
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEUCOVORIN CALCIUM
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 30 July 2020
- Application: ANDA211132
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2020
- Application: ANDA213929
- Marketing authorisation holder: LEADING
- Local brand name: LEUCOVORIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 2023
- Application: ANDA217021
- Marketing authorisation holder: HAINAN POLY
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 July 2023
- Application: ANDA216590
- Marketing authorisation holder: MEITHEAL
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 November 2025
- Application: ANDA218200
- Marketing authorisation holder: GLAND
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 February 2026
- Application: NDA220406
- Marketing authorisation holder: AVYXA HOLDINGS
- Local brand name: VYKOURA
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA089353
- Marketing authorisation holder: ABIC
- Local brand name: LEUCOVORIN CALCIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089352
- Marketing authorisation holder: ABIC
- Local brand name: LEUCOVORIN CALCIUM
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA
- Application: ANDA088939
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: LEUCOVORIN CALCIUM
- 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: 20 April 2025 – 20 April 2026
- Total reports: 9,133
Most-reported reactions
- Diarrhoea — 1,574 reports (17.23%)
- Neutropenia — 1,223 reports (13.39%)
- Nausea — 1,076 reports (11.78%)
- Off Label Use — 854 reports (9.35%)
- Vomiting — 839 reports (9.19%)
- Neuropathy Peripheral — 788 reports (8.63%)
- Fatigue — 757 reports (8.29%)
- Thrombocytopenia — 730 reports (7.99%)
- Disease Progression — 651 reports (7.13%)
- Pyrexia — 641 reports (7.02%)
Folinic Acid 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 Folinic Acid approved in United States?
Yes. FDA authorised it on 4 March 1987; FDA authorised it on 14 September 1987; FDA authorised it on 28 March 1988.
Who is the marketing authorisation holder for Folinic Acid in United States?
XANODYNE PHARM holds the US marketing authorisation.