FDA — authorised 6 December 1949
- Application: NDA007085
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Vitamin B12 in United States
FDA authorised Vitamin B12 on 6 December 1949 · 71,913 US adverse-event reports
Marketing authorisations
FDA — authorised 14 July 1958
- Application: NDA010791
- Marketing authorisation holder: BEL MAR
- Local brand name: RUBIVITE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 1971
- Application: ANDA080515
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 April 1972
- Application: ANDA080737
- Marketing authorisation holder: AM REGENT
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 September 1972
- Application: ANDA083022
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DODEX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 March 1973
- Application: ANDA080554
- Marketing authorisation holder: WYETH AYERST
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 1973
- Application: ANDA080557
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 June 1973
- Application: ANDA080689
- Marketing authorisation holder: DELL LABS
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 January 1974
- Application: ANDA080573
- Marketing authorisation holder: DR REDDYS
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 1974
- Application: ANDA084264
- Marketing authorisation holder: WEST WARD
- Local brand name: CYANOCOBALAMIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 1974
- Application: NDA017406
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: DICOPAC KIT
- Indication: N/A — N/A
- Status: approved
FDA — authorised 12 September 1979
- Application: ANDA083075
- Marketing authorisation holder: LYPHOMED
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 1980
- Application: NDA011208
- Marketing authorisation holder: ARMOUR PHARM
- Local brand name: DEPINAR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 1982
- Application: ANDA080564
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 November 1996
- Application: NDA019722
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: NASCOBAL
- Indication: GEL, METERED — NASAL
- Status: approved
FDA — authorised 23 September 2003
- Application: ANDA040451
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 July 2007
- Application: NDA022102
- Marketing authorisation holder: PH HEALTH
- Local brand name: CALOMIST
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 11 December 2015
- Application: ANDA206503
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 June 2017
- Application: ANDA204829
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 2018
- Application: ANDA209429
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 September 2020
- Application: ANDA212458
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CYANOCOBALAMIN
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA214390
- Marketing authorisation holder: GLAND
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2020
- Application: ANDA213874
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 January 2021
- Application: ANDA212915
- Marketing authorisation holder: SANDOZ
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 2022
- Application: ANDA215417
- Marketing authorisation holder: SOLA PHARMS
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 November 2022
- Application: ANDA215107
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 July 2024
- Application: ANDA217839
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 November 2024
- Application: ANDA214316
- Marketing authorisation holder: MEITHEAL
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083064
- Marketing authorisation holder: WATSON LABS
- Local brand name: COBAVITE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087969
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083013
- Marketing authorisation holder: WATSON LABS
- Local brand name: COBAVITE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087551
- Marketing authorisation holder: SOLOPAK
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA006798
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: BERUBIGEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA006668
- Marketing authorisation holder: MERCK
- Local brand name: REDISOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA083120
- Marketing authorisation holder: WATSON LABS
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080510
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080668
- Marketing authorisation holder: LUITPOLD
- Local brand name: CYANOCOBALAMIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080570
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: RUVITE
- 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: 22 April 2025 – 22 April 2026
- Total reports: 71,913
Most-reported reactions
- Fatigue — 11,831 reports (16.45%)
- Diarrhoea — 8,427 reports (11.72%)
- Nausea — 8,177 reports (11.37%)
- Headache — 6,937 reports (9.65%)
- Drug Ineffective — 6,923 reports (9.63%)
- Off Label Use — 6,478 reports (9.01%)
- Pain — 6,051 reports (8.41%)
- Dizziness — 5,868 reports (8.16%)
- Dyspnoea — 5,702 reports (7.93%)
- Asthenia — 5,519 reports (7.67%)
Frequently asked questions
Is Vitamin B12 approved in United States?
Yes. FDA authorised it on 6 December 1949; FDA authorised it on 14 July 1958; FDA authorised it on 20 October 1971.
Who is the marketing authorisation holder for Vitamin B12 in United States?
WARNER CHILCOTT holds the US marketing authorisation.