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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
OSMOPREPSalix PharmaceuticalsN-021892 RX2006-03-16
1 products, RLD, RS
Show 1 discontinued
Sodium phosphate
+
dibasic
+
heptahydrate
+
Sodium phosphate
+
monobasic
+
anhydrous
Tradename
Company
Number
Date
Products
SODIUM PHOSPHATES IN PLASTIC CONTAINERHospiraN-018892 RX1983-05-10
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
crest 3d whiteOTC monograph final2023-06-15
osmoprepNew Drug Application2019-03-04
potassium phosphatesunapproved drug other2022-07-12
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
76870752028-06-22DS, 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
ContraceptionD0032671161018
Breast neoplasmsD001943EFO_0003869C50221510
HivD006678O98.711136
NeoplasmsD009369C802125
Contraception behaviorD003268123
Intrauterine device expulsionD007433112
ThinnessD013851HP_0004325R63.611
InflammationD00724911
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_00005152516
PregnancyD011247EFO_0002950Z33.1123
Menkes kinky hair syndromeD00770611113
Hiv infectionsD015658EFO_0000764B20112
GliomaD005910EFO_0000520111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C612114
Pancreatic neoplasmsD010190EFO_0003860C2511
Amyotrophic lateral sclerosisD000690EFO_0000253G12.21111
Alzheimer diseaseD000544EFO_0000249F0311
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230112
Multiple myelomaD009101C90.011
Urologic neoplasmsD014571C64-C6811
Ovarian neoplasmsD010051EFO_0003893C5611
Bacterial vaginosisD016585EFO_000393211
SarcomaD01250911
Rectal neoplasmsD01200411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cross infectionD00342833
Postcoital contraceptionD04436322
Diabetic footD017719EFO_100145922
Wounds and injuriesD014947T14.822
Blood coagulation disordersD001778EFO_0009314D68.911
Stomach neoplasmsD013274EFO_0003897C1611
Prediabetic stateD011236EFO_1001121R73.0311
HyperglycemiaD006943HP_0003074R73.911
Type 2 diabetes mellitusD003924EFO_0001360E1111
Glucose intoleranceD018149HP_0000833R73.0311
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUORIDE
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-ID7664-39-3
RxCUI
ChEMBL IDCHEMBL1232767
ChEBI ID29228
PubChem CID28179
DrugBank
UNII ID
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 312,550 documents
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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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