FDA — authorised 5 June 1947
- Application: NDA005897
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: FOLVITE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Folate in United States
FDA authorised Folate on 5 June 1947 · 5,861 US adverse-event reports
Marketing authorisations
FDA — authorised 23 December 1971
- Application: ANDA080680
- Marketing authorisation holder: WATSON LABS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 1972
- Application: ANDA080600
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 1972
- Application: ANDA083000
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 July 1973
- Application: ANDA080686
- Marketing authorisation holder: IMPAX LABS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 1973
- Application: ANDA080691
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 1973
- Application: ANDA083526
- Marketing authorisation holder: MK LABS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 1974
- Application: ANDA084158
- Marketing authorisation holder: PHARMERAL
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1976
- Application: ANDA085141
- Marketing authorisation holder: WATSON LABS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 1983
- Application: ANDA088199
- Marketing authorisation holder: UDL
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 1986
- Application: ANDA089202
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FOLIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 1993
- Application: ANDA081066
- Marketing authorisation holder: BEN VENUE
- Local brand name: FOLIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 June 2005
- Application: ANDA040514
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 2005
- Application: ANDA040582
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2005
- Application: ANDA040625
- Marketing authorisation holder: AMNEAL PHARM
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2013
- Application: ANDA091145
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2014
- Application: ANDA202437
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 2015
- Application: ANDA204418
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2019
- Application: ANDA211064
- Marketing authorisation holder: RISING
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 November 2019
- Application: ANDA202522
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: FOLIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083598
- Marketing authorisation holder: HALSEY
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088949
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- 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: 5,861
Most-reported reactions
- Pneumonia — 753 reports (12.85%)
- Vomiting — 739 reports (12.61%)
- Dyspnoea — 724 reports (12.35%)
- Asthma — 624 reports (10.65%)
- Oedema — 584 reports (9.96%)
- Drug Hypersensitivity — 580 reports (9.9%)
- Wheezing — 540 reports (9.21%)
- Pain — 506 reports (8.63%)
- Malaise — 435 reports (7.42%)
- Cough — 376 reports (6.42%)
Folate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Folate approved in United States?
Yes. FDA authorised it on 5 June 1947; FDA authorised it on 23 December 1971; FDA authorised it on 31 March 1972.
Who is the marketing authorisation holder for Folate in United States?
WYETH PHARMS INC holds the US marketing authorisation.