FDA — authorised 13 August 1946
- Marketing authorisation holder: LEDERLE
- Status: approved
🇺🇸 Folic Acid in United States
FDA authorised Folic Acid on 13 August 1946
Marketing authorisations
FDA — authorised 5 June 1947
- Application: NDA005897
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: FOLVITE
- Indication: TABLET — ORAL
- Status: approved
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 2 November 1972
- Application: ANDA080784
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1973
- Application: ANDA083141
- Marketing authorisation holder: WATSON LABS
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 1973
- Application: ANDA080755
- Marketing authorisation holder: EVERYLIFE
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 1973
- Application: ANDA083133
- Marketing authorisation holder: TABLICAPS
- 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 6 May 1974
- Application: ANDA080816
- Marketing authorisation holder: LANNETT
- 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 4 February 1976
- Application: ANDA084915
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 1976
- Application: ANDA085061
- Marketing authorisation holder: CONTRACT PHARMACAL
- 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 23 March 1984
- Application: ANDA088730
- Marketing authorisation holder: VANGARD
- 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 January 2009
- Application: ANDA040796
- Marketing authorisation holder: LEADING
- Status: approved
FDA — authorised 9 June 2009
- Application: ANDA090035
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: FOLIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 June 2010
- Application: ANDA040756
- Marketing authorisation holder: PH HEALTH
- 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 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- 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 — authorised 26 January 2026
- Application: NDA216395
- Marketing authorisation holder: SOLUBIOMIX
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Folic Acid (NDA216395) for a new dosage form on 26 January 2026. This approval was granted to SOLUBIOMIX, the marketing authorisation holder. The approval was made under the standard expedited pathway.
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
Folic Acid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Folic Acid approved in United States?
Yes. FDA authorised it on 13 August 1946; FDA authorised it on 5 June 1947; FDA authorised it on 23 December 1971.
Who is the marketing authorisation holder for Folic Acid in United States?
LEDERLE holds the US marketing authorisation.