Infuvite adult, Fosavance(cholecalciferol)
Adrovance, Alendronic Acid / Colecalciferol, Fosamax D, Fosavance, Infuvite, Vantavo (cholecalciferol) is a small molecule pharmaceutical. Cholecalciferol was first approved as Infuvite adult on 2000-05-18. It is used to treat cardiovascular diseases, chronic kidney failure, crohn disease, familial hypophosphatemic rickets, and hypoparathyroidism amongst others in the USA. It has been approved in Europe to treat postmenopausal osteoporosis.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Combinations
Fosamax d, Infuvite
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alendronate sodium
+
Cholecalciferol
Alpha-tocopherol acetate
+
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin k
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Tocopherol acetate
+
Vitamin a
+
Vitamin k
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 3 pack family dollar instant hand sanitizers | OTC monograph not final | 2014-11-28 |
| a and d | OTC monograph final | 2020-01-07 |
| a and d plus e | OTC monograph final | 2020-11-06 |
| adult infuvite multiple vitamins | New Drug Application | 2019-05-14 |
| adult infuvite multiple vitamins for infusion pharmacy bulk | New Drug Application | 2013-01-01 |
| ag international | OTC monograph final | 2019-07-23 |
| ameriderm | OTC monograph final | 2022-01-13 |
| animi-3 | unapproved drug other | 2013-02-06 |
| animi-3 with vitamin d | unapproved drug other | 2011-05-23 |
| anubis barcelona | OTC monograph final | 2023-09-01 |
Show 177 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11C: Vitamin a and d, incl. combinations of the two
— A11CC: Vitamin d and analogues
— A11CC05: Colecalciferol
— A11CC55: Colecalciferol, combinations
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB03: Alendronic acid and colecalciferol
— M05BB04: Risedronic acid, calcium and colecalciferol, sequential
— M05BB05: Alendronic acid, calcium and colecalciferol, sequential
— M05BB07: Risedronic acid and colecalciferol
— M05BB08: Zoledronic acid, calcium and colecalciferol, sequential
— M05BB09: Ibandronic acid and colecalciferol
— M05BX: Other drugs affecting bone structure and mineralization in atc
— M05BX53: Strontium ranelate and colecalciferol
HCPCS
No data
Clinical
Clinical Trials
4254 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | 42 | 70 | 57 | 85 | 396 | 626 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | 12 | 24 | 44 | 32 | 68 | 176 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 8 | 6 | 12 | 82 | 110 |
| Covid-19 | D000086382 | — | U07.1 | 8 | 15 | 17 | 7 | 58 | 101 |
| Chronic renal insufficiency | D051436 | — | N18 | 8 | 16 | 17 | 25 | 27 | 88 |
| Healthy volunteers/patients | — | — | — | 31 | 4 | 3 | 2 | 44 | 83 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 4 | 15 | 10 | 12 | 42 | 78 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 25 | 28 | 15 | 1 | 17 | 74 |
| Neoplasms | D009369 | — | C80 | 33 | 16 | 9 | 4 | 10 | 63 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 3 | 8 | 10 | 22 | 16 | 57 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 12 | 27 | 15 | — | 10 | 51 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 3 | 1 | — | 24 | 30 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | 1 | 4 | — | 20 | 27 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 12 | 16 | 2 | — | 3 | 26 |
| Lymphoma | D008223 | — | C85.9 | 10 | 9 | 3 | — | 2 | 22 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 5 | 6 | — | 10 | 20 |
| Melanoma | D008545 | — | — | 8 | 8 | 2 | — | 5 | 19 |
| Leukemia | D007938 | — | C95 | 5 | 13 | 3 | — | — | 18 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 3 | 2 | 1 | — | 12 | 17 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 3 | 2 | 2 | — | 11 | 17 |
Show 185 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 10 | 11 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 8 | 4 | — | — | — | 10 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 7 | 4 | — | — | 1 | 10 |
| Hepatitis d | D003699 | EFO_0007304 | — | 1 | 5 | — | — | 4 | 10 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | 6 | 7 |
| Bone density | D015519 | EFO_0003923 | M85 | — | 1 | — | — | 6 | 7 |
| Small cell lung carcinoma | D055752 | — | — | 6 | 4 | — | — | — | 7 |
| Nutrition disorders | D009748 | EFO_0001069 | — | 1 | 2 | — | — | 5 | 7 |
| Exercise | D015444 | EFO_0000483 | — | — | 1 | — | — | 6 | 7 |
| Chronic pain | D059350 | HP_0012532 | — | 1 | 2 | — | — | 3 | 6 |
Show 194 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | — | — | — | 8 | 9 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | — | — | — | 7 | 8 |
| Heart disease risk factors | D000082742 | — | — | 2 | — | — | — | 5 | 7 |
| Nutritional status | D009752 | — | — | 1 | — | — | — | 5 | 6 |
| Muscle strength | D053580 | — | — | 1 | — | — | — | 4 | 5 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | 4 | 5 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | — | — | — | 4 | 5 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | — | — | — | 4 | 5 |
| Diet therapy | D004035 | — | — | 1 | — | — | — | 3 | 4 |
| Gastrointestinal microbiome | D000069196 | — | — | 2 | — | — | — | 2 | 4 |
Show 46 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 9 | 9 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 6 | 6 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 6 | 6 |
| Body composition | D001823 | — | — | — | — | — | — | 5 | 5 |
| Body weight changes | D001836 | — | — | — | — | — | — | 5 | 5 |
| Child development | D002657 | — | — | — | — | — | — | 4 | 4 |
| Fertilization in vitro | D005307 | — | — | — | — | — | — | 4 | 4 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | — | — | — | 4 | 4 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 4 | 4 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | — | — | — | 4 | 4 |
Show 323 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cholecalciferol |
| INN | colecalciferol |
| Description | Fosamax Plus D (cholecalciferol) is a small molecule pharmaceutical. Cholecalciferol was first approved as Fosamax plus d on 2005-04-07. It is used to treat cardiovascular diseases, chronic kidney failure, crohn disease, familial hypophosphatemic rickets, and hypoparathyroidism amongst others in the USA. |
| Classification | Small molecule |
| Drug class | vitamin D analogs |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C1CC[C@H](O)C/C1=C/C=C1\CCC[C@@]2(C)[C@H]1CC[C@@H]2[C@H](C)CCCC(C)C |
Identifiers
| PDB | — |
| CAS-ID | 67-97-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1042 |
| ChEBI ID | 28940 |
| PubChem CID | 5280795 |
| DrugBank | DB00169 |
| UNII ID | 1C6V77QF41 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Citranatal, Citranatal 90 dha, Citranatal assure, Citranatal b-calm, Citranatal dha, Citranatal essence, Citranatal harmony, Citranatal harmony 2.1, Citranatal harmony 3.0, Citranatal medley, Citranatal rx, Healthy mamabe well rounded, Marnatal f, Moms choice rx, Natafort, Neonatal complete, Neonatal dha, Nestabs, Nestabs dha, Nestabs one, O-cal prenatal vitamin, Omega-3 well pack, Pnv prenatal plus multivitamin, Pnv prenatal vitamin, Pnv-dha, Pnv-omega, Pnv-select, Pr natal 400, Pr natal 400 ec, Pr natal 430, Pr natal 430 ec, Pre-tabs dha, Prenaissance, Prenaissance plus, Prenata, Prenatal plus multivitamin plus dha minicaps, Prenate dha, Prenate elite, Prenate enhance, Prenate essential, Prenate mini, Prenate pixie, Prenate restore, Primacare, Select ob, Select-ob plus dha, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha
Adverse Events
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10,757 adverse events reported
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