Fluoride
Osmoprep, Phosphates (fluoride) is a small molecule pharmaceutical. Fluoride was first approved as Sodium phosphates in plastic container on 1983-05-10.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Combinations
Osmoprep, Phosphates (generic drugs available since 2011-12-30, discontinued: Visicol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sodium phosphate
+
dibasic
+
anhydrous
+
Sodium phosphate
+
monobasic
+
monohydrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OSMOPREP | Salix Pharmaceuticals | N-021892 RX | 2006-03-16 | 1 products, RLD, RS |
Show 1 discontinued
Sodium phosphate
+
dibasic
+
heptahydrate
+
Sodium phosphate
+
monobasic
+
anhydrous
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SODIUM PHOSPHATES IN PLASTIC CONTAINER | Hospira | N-018892 RX | 1983-05-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| crest 3d white | OTC monograph final | 2023-06-15 |
| osmoprep | New Drug Application | 2019-03-04 |
| potassium phosphates | unapproved drug other | 2022-07-12 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sodium Phosphate, Dibasic, Anhydrous / Sodium Phosphate, Monobasic, Monohydrate, Osmoprep, Salix Pharms | |||
| 7687075 | 2028-06-22 | DS, DP | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AA: Caries prophylactic agents
— A01AA01: Sodium fluoride
— A01AA04: Stannous fluoride
— A01AA51: Sodium fluoride, combinations
— A12: Mineral supplements
— A12C: Other mineral supplements in atc
— A12CD: Fluoride supplements
— A12CD01: Sodium fluoride
— A12CD51: Fluoride, combinations
V: Various drug classes in atc
— V09: Diagnostic radiopharmaceuticals
— V09I: Tumour detection radiopharmaceuticals
— V09IX: Other diagnostic radiopharmaceuticals for tumour detection in atc
— V09IX06: Sodium fluoride (18f)
HCPCS
Code | Description |
|---|---|
| A9580 | Sodium fluoride f-18, diagnostic, per study dose, up to 30 millicuries |
| Level 3: D1206-D1208 | Topical Fluoride Treatment (office procedure) |
| Q9950 | Injection, sulfur hexafluoride lipid microspheres, per ml |
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | 1 | 1 | 6 | 10 | 18 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 2 | — | 1 | 5 | 10 |
| Hiv | D006678 | O98.7 | 1 | 1 | — | 1 | 3 | 6 | |
| Neoplasms | D009369 | C80 | 2 | — | — | 1 | 2 | 5 | |
| Contraception behavior | D003268 | — | — | — | 1 | 2 | 3 | ||
| Intrauterine device expulsion | D007433 | — | — | — | 1 | 1 | 2 | ||
| Thinness | D013851 | HP_0004325 | R63.6 | — | — | — | 1 | — | 1 |
| Inflammation | D007249 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | 2 | 5 | 1 | — | — | 6 | |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | 2 | 3 |
| Menkes kinky hair syndrome | D007706 | 1 | 1 | 1 | — | 1 | 3 | ||
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | 2 | 1 | — | — | 1 | 4 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cross infection | D003428 | — | — | — | — | 3 | 3 | ||
| Postcoital contraception | D044363 | — | — | — | — | 2 | 2 | ||
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | — | 2 | 2 | |
| Wounds and injuries | D014947 | T14.8 | — | — | — | — | 2 | 2 | |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FLUORIDE |
| INN | — |
| Description | Fluorine F-18, Sodium Fluoride F 18 (fluoride) is a small molecule pharmaceutical. Fluoride was first approved as Fluorine F-18 on 1982-01-01. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | F |
Identifiers
| PDB | — |
| CAS-ID | 7664-39-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1232767 |
| ChEBI ID | 29228 |
| PubChem CID | 28179 |
| DrugBank | — |
| UNII ID | — |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Osmoprep
Adverse Events
Top Adverse Reactions
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400,121 adverse events reported
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