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Isosorbide
Bidil, Ismotic, Isordil, Monoket (isosorbide) is a small molecule pharmaceutical. Isosorbide was first approved as Ismotic on 1982-01-01. It is used to treat angina pectoris, coronary disease, cyanosis, diffuse esophageal spasm, and gastroesophageal reflux amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
Trade Name
FDA
EMA
Isordil, Monoket (generic drugs available since 1987-03-12, discontinued: Dilatrate-sr, Imdur, Ismo, Ismotic, Sorbitrate)
Combinations
Bidil (generic drugs available since 1987-03-12)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydralazine hydrochloride
+
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
BIDILAzurityN-020727 RX2005-06-23
1 products, RLD, RS
Isosorbide
Tradename
Company
Number
Date
Products
ISMOTICAlcon ResearchN-017063 DISCN1982-01-01
1 products
Hide discontinued
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
ISORDILBausch Health CompaniesN-012093 RX1988-07-29
2 products, RLD
Show 7 discontinued
Isosorbide mononitrate
Tradename
Company
Number
Date
Products
MONOKETECI PharmaceuticalsN-020215 RX1993-06-30
2 products, RLD
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bidilNew Drug Application2021-01-26
ismotic2006-03-23
isordilNew Drug Application2019-08-08
isosorbide mononitrateANDA2022-10-31
monoketNew Drug Application2015-02-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
angina pectorisEFO_0003913D000787I20
coronary disease—D003327—
cyanosis—D003490R23.0
diffuse esophageal spasmEFO_1001785D015155K22.4
gastroesophageal refluxEFO_0003948D005764K21
heart failureEFO_0003144D006333I50
poisoningEFO_0008546D011041T65.91
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01D: Vasodilators used in cardiac diseases
— C01DA: Organic nitrates used in cardiac disease
— C01DA08: Isosorbide dinitrate
— C01DA14: Isosorbide mononitrate
— C01DA58: Isosorbide dinitrate, combinations
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AE: Muscle relaxants for treatment of hemorrhoids and anal fissures for topical use
— C05AE02: Isosorbide dinitrate
HCPCS
No data
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameISOSORBIDE
INNisosorbide
Description
Isosorbide is an organic molecular entity.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O[C@H]1CO[C@@H]2[C@H](O)CO[C@H]12
Identifiers
PDB—
CAS-ID652-67-5
RxCUI6057
ChEMBL IDCHEMBL1200660
ChEBI ID—
PubChem CID12597
DrugBankDB09401
UNII IDWXR179L51S (ChemIDplus, GSRS)
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:
Mock data
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Additional graphs summarizing 7,589 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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