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Drug ReportsTiotropium bromide anhydrous
Tiotropium bromide anhydrous
Spiriva, Stiolto, Tiotropium (tiotropium bromide anhydrous) is an unknown pharmaceutical. Tiotropium bromide anhydrous was first approved as Spiriva on 2004-01-30.
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Abbreviated New Drug Application (ANDA)
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Brand Name
Status
Last Update
spirivaNew Drug Application2025-09-02
spiriva respimatNew Drug Application2025-01-07
stiolto respimatNew Drug Application2025-06-30
tiotropium bromideANDA2025-04-30
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FDA Information
Olodaterol Hydrochloride / Tiotropium Bromide, Stiolto Respimat, Boehringer Ingelheim
87333412030-10-16DP
78372352028-03-13DP
90279672027-03-31DP
77279842027-01-19DP
73963412026-10-10DP
72207422025-05-12DS, DPU-1703
80348092025-05-12U-1702
Tiotropium Bromide, Spiriva, Boehringer Ingelheim
80220822026-01-19DPU-1186
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL06: Olodaterol and tiotropium bromide
— R03AL10: Formoterol and tiotropium bromide
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BB: Anticholinergics inhalants for obstructive airway diseases
— R03BB04: Tiotropium bromide
— R03BB54: Tiotropium bromide, combinations
HCPCS
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Clinical
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426 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9——1——1
Obstructive lung diseasesD008173————1——1
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTiotropium bromide anhydrous
INNtiotropium bromide
Description
Tiotropium bromide is an organic bromide salt having (1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane as the counterion. Used (in the form of the hydrate) for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. It has a role as a bronchodilator agent and a muscarinic antagonist. It is an organic bromide salt and a quaternary ammonium salt.
Classification
Unknown
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
C[N+]1(C)[C@H]2C[C@H](OC(=O)C(O)(c3cccs3)c3cccs3)C[C@@H]1[C@H]1O[C@@H]21.[Br-]
Identifiers
PDB—
CAS-ID136310-93-5
RxCUI—
ChEMBL IDCHEMBL4440620
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDXX112XZP0J (ChemIDplus, GSRS)
Target
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PubMed Central
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Safety
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10,911 adverse events reported
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