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Torasemide

Generic Name
Torasemide
Brand Names
Demadex, Soaanz
Drug Type
Small Molecule
Chemical Formula
C16H20N4O3S
CAS Number
56211-40-6
Unique Ingredient Identifier
W31X2H97FB

Overview

Torasemide is a high-ceiling loop diuretic. Structurally, it is a pyridine-sulfonylurea used as an antihypertensive agent. Torasemide was first approved for clinical use by the FDA in 1993.

Indication

Torasemide is indicated for the treatment of edema associated with congestive heart failure, renal or hepatic diseases. From this condition, it has been observed that torasemide is very effective in cases of kidney failure. As well, torasemide is approved to be used as an antihypertensive agent either alone or in combination with other antihypertensives.

Associated Conditions

  • Edema
  • Hypertension

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/27
Phase 4
Terminated
2024/11/01
Phase 2
Recruiting
Jemincare
2024/05/14
Phase 3
Completed
Ospedale San Raffaele
2024/03/04
Phase 1
Completed
2024/02/23
Phase 4
Recruiting
National Institute of Cardiology, Warsaw, Poland
2024/01/23
Phase 4
Recruiting
2024/01/16
Phase 2
Recruiting
2023/09/15
N/A
Recruiting
China National Center for Cardiovascular Diseases
2023/09/15
N/A
Recruiting
China National Center for Cardiovascular Diseases
2023/09/14
N/A
Recruiting
China National Center for Cardiovascular Diseases

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sarfez Pharmaceuticals Inc
73502-286
ORAL
20 mg in 1 1
12/28/2021
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-874
ORAL
100 mg in 1 1
7/17/2023
Teva Pharmaceuticals USA, Inc.
50111-915
ORAL
5 mg in 1 1
2/28/2017
Carilion Materials Management
68151-2946
ORAL
5 mg in 1 1
10/3/2012
Camber Pharmaceuticals, Inc.
31722-530
ORAL
10 mg in 1 1
8/18/2017
Bryant Ranch Prepack
63629-1346
ORAL
10 mg in 1 1
5/23/2023
Rising Health, LLC
57237-141
ORAL
100 mg in 1 1
6/14/2023
Aurobindo Pharma Limited
65862-125
ORAL
5 mg in 1 1
6/14/2023
Rising Health, LLC
57237-138
ORAL
5 mg in 1 1
6/14/2023
Sarfez Pharmaceuticals Inc
73502-288
ORAL
60 mg in 1 1
12/28/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DEMADEX TABLETS - 5MG
Hoffmann-La Roche Limited
02129000
Tablet - Oral
5 MG
12/31/1995
DEMADEX TABLETS - 100MG
Hoffmann-La Roche Limited
02129035
Tablet - Oral
100 MG
12/31/1995
DEMADEX TABLETS - 20MG
Hoffmann-La Roche Limited
02129027
Tablet - Oral
20 MG
12/31/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TORASEMIDA SANDOZ 10 MG COMPRIMIDOS EFG
Sandoz Farmaceutica S.A.
66332
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
SUTRIL NEO 10 mg COMPRIMIDOS DE LIBERACION PROLONGADA
67987
COMPRIMIDO DE LIBERACIÓN PROLONGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
TORASEMIDA SANDOZ 5 MG COMPRIMIDOS EFG
Sandoz Farmaceutica S.A.
66331
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TORASEMIDA NORMON 5 mg COMPRIMIDOS EFG
Laboratorios Normon S.A.
67313
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
SUTRIL NEO 5 mg COMPRIMIDOS DE LIBERACION PROLONGADA
67986
COMPRIMIDO DE LIBERACIÓN PROLONGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
TORASEMIDA ARISTO 5 mg COMPRIMIDOS EFG
Aristo Pharma Iberia S.L.
68265
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
TORASEMIDA NORMON 10 mg COMPRIMIDOS EFG
Laboratorios Normon S.A.
67314
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TORASEMIDA NORMON 2,5 mg COMPRIMIDOS EFG
Laboratorios Normon S.A.
67312
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TORASEMIDA CINFA 5 mg COMPRIMIDOS EFG
Laboratorios Cinfa S.A.
66314
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TORASEMIDA COMBIX 10 mg COMPRIMIDOS EFG
Laboratorios Combix S.L.U.
66429
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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