Overview
Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as flavin mononucleotide and flavin-adenine dinucleotide.
Indication
For the treatment of ariboflavinosis (vitamin B2 deficiency).
Associated Conditions
- Ariboflavinosis
- Beriberi
- Constipation
- Functional Gastrointestinal Disorders (FGID)
- Joint Pain
- Metabolic cardiomyopathy
- Migraine
- Myalgia
- Neuropathic Pain
- Peripheral neuritis
- Peripheral paralysis
- Vitamin B complex deficiency
- Vitamin B1 deficiency
- Vitamin Deficiency
- Wernicke's encephalopathy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/18 | Early Phase 1 | Completed | Steven Moore | ||
2023/05/31 | Not Applicable | Not yet recruiting | |||
2021/08/30 | Phase 3 | Recruiting | Cornea and Laser Eye Institute | ||
2021/05/27 | Phase 3 | Recruiting | Cornea and Laser Eye Institute | ||
2021/05/21 | Phase 3 | Recruiting | Cornea and Laser Eye Institute | ||
2021/02/01 | Early Phase 1 | Not yet recruiting | Kent Wellish MD | ||
2020/10/12 | Not Applicable | Not yet recruiting | Joseph B. Ciolino, MD | ||
2020/06/11 | Phase 4 | Completed | |||
2020/01/18 | Phase 2 | UNKNOWN | |||
2019/09/20 | Phase 3 | Completed | Thomas M. Lietman |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvPAK | 50268-677 | ORAL | 3 mg in 1 1 | 4/12/2022 | |
| CarWin Pharmaceutical Associates, LLC | 15370-105 | ORAL | 1.3 mg in 1 1 | 1/10/2024 | |
| Method Pharmaceuticals, LLC | 58657-164 | ORAL | 1.2 mg in 1 1 | 12/9/2023 | |
| Exeltis USA, Inc. | 0642-7473 | ORAL | 1.8 mg in 1 1 | 2/14/2023 | |
| Marnel Pharmaceuticals, Inc. | 0682-3001 | ORAL | 20 mg in 1 1 | 5/2/2014 | |
| Centurion Labs, LLC | 23359-105 | ORAL | 3 mg in 1 1 | 1/22/2024 | |
| PureTek Corporation | 59088-193 | ORAL | 3.4 mg in 1 1 | 1/11/2023 | |
| BonGeo Pharmaceuticals, Inc. | 52796-174 | ORAL | 1.5 mg in 1 1 | 2/2/2024 | |
| Cameron Pharmaceuticals | 42494-432 | ORAL | 1.2 mg in 1 1 | 9/18/2023 | |
| Carilion Materials Management | 68151-2640 | ORAL | 3 mg in 1 1 | 4/1/2013 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENZYPLEX TABLET | SIN06211P | ENTERIC COATED TABLET | 5 mg | 5/3/1991 | |
| IBERET-FOLIC-500 TABLET | SIN05447P | TABLET, FILM COATED | 6 mg | 2/19/1991 | |
| FBC FILMTAB | SIN05814P | TABLET, FILM COATED | 2 mg | 5/3/1991 | |
| CERNEVIT FOR INJECTION | SIN11975P | INJECTION, POWDER, FOR SOLUTION | 4.14 mg/vial | 6/5/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MULTIMAX SYRUP | N/A | N/A | N/A | 7/8/2014 | |
| CERNEVIT FOR INJ | N/A | N/A | N/A | 4/18/2008 | |
| BIOCATALIN INJECTABLE SOLN (VET) | N/A | N/A | N/A | 8/9/1984 | |
| CHLORAFORTE CAP | N/A | N/A | N/A | 6/2/1992 | |
| BIHAKU TAB | N/A | N/A | N/A | 7/1/1994 | |
| BOGEN-50 S C TAB | N/A | N/A | N/A | 4/28/1982 | |
| HUAZIN INJ | N/A | N/A | N/A | 4/28/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Energy Multi | 453128 | Medicine | A | 6/21/2024 | |
| Cellula-T oral powder jar | 43995 | Hong Sp & Hs | Medicine | A | 4/13/1993 |
| Men's Multi | 326959 | Medicine | A | 12/2/2019 | |
| Super B Complex tablets | 126510 | Medicine | A | 3/28/2006 | |
| BLACKMORES SUPERKIDS MULTI CHEWABLES | 289492 | Medicine | A | 5/30/2017 | |
| BLACKMORES B+C TABLETS | 215811 | Medicine | A | 10/9/2013 | |
| Wealthy Health Bio-Maxi B Excellent Stress Relief Formula with Herbs | 139048 | Medicine | A | 5/21/2007 | |
| Caruso's Hair Food | 130857 | Medicine | A | 8/30/2006 | |
| MaxN-Fuze Multivitamins | 288444 | Max Health & Living Australia Pty Ltd | Medicine | A | 5/1/2017 |
| Berocca Performance Original effervescent tablets | 193893 | Medicine | A | 1/17/2012 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CENTURY PLUS | vita health products inc | N/A | Tablet - Oral | 3.2 MG / TAB | 2/5/1998 |
| STRESS B COMPLEX WITH C AND E TAB | 02008947 | Tablet - Oral | 10 MG / TAB | 12/31/1993 | |
| STRESS B CAPSULES WITH VITAMIN C | rheingold food international ltd. | 00694509 | Capsule - Oral | 50 MG / CAP | 12/31/1987 |
| MULTIPLE VITAMINS PLUS IRON FOR WOMEN | pharmetics (2011) inc | 02239678 | Tablet - Oral | 1.7 MG / TAB | 8/16/1999 |
| MOR-VITES TAB | pharmetics (2011) inc | 01911236 | Tablet - Oral | 3 MG | 12/31/1992 |
| B2 TAB 100MG | vita health products inc | 00450650 | Tablet - Oral | 100 MG | 12/31/1979 |
| VITAMIN B2 100MG | great earth companies, inc. | 02230623 | Tablet - Oral | 100 MG | 8/25/1998 |
| LIQUI B COMPLEX PLUS | twin laboratories inc. | 01984411 | Liquid - Oral | 10 MG / ML | 12/31/1995 |
| POLYMINE AVEC ZINC ET CUIVRE | les laboratoires vachon inc. | 00630888 | Tablet - Oral | 10 MG | 12/31/1985 |
| Q.T. #4 VITAMIN AND MINERAL DIETARY SUPPLEMENT | garden state nutritionals | 02238953 | Tablet - Oral | 0.57 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BECOZYME C FORTE COMPRIMIDOS RECUBIERTOS | Bayer Hispania S.L. | 40869 | COMPRIMIDO RECUBIERTO | Sin Receta | Commercialized |
| ELEVIT COMPRIMIDOS RECUBIERTOS CON PELICULA | Bayer Hispania S.L. | 67267 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized |
| HIDROPOLIVIT A MINERAL COMPRIMIDOS MASTICABLES | Laboratorios Menarini S.A. | 44019 | COMPRIMIDO MASTICABLE | Sin Receta | Not Commercialized |
| HIDROPOLIVIT GOTAS ORALES EN SOLUCION | Laboratorios Menarini S.A. | 44000 | GOTAS ORALES EN SOLUCIÓN | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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