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Generic Name: dutasteride

Summary for Generic Name: dutasteride

Tradenames:4
Patents:3
Applicants:3
NDAs:4
Drug Master File Entries: see list15
Suppliers: see list3
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)

Pharmacology for Ingredient: dutasteride

Tentative approvals for DUTASTERIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE;ORAL0.5MG
<disabled><disabled>CAPSULE; ORAL0.5MG
<disabled><disabled>CAPSULE;ORAL0.5MG

Clinical Trials for: dutasteride

Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
Status: Terminated Condition: Prostate Cancer

Efficacy and Safety Study of Dutasteride Combined With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Status: Active, not recruiting Condition: BPH

Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males.
Status: Completed Condition: Prostatic Hyperplasia

TRADE-Testosterone Replacement and Dutasteride Effectiveness
Status: Completed Condition: Hypogonadism; Benign Prostatic Hyperplasia

Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Status: Completed Condition: Hypogonadism; Hypogonadism, Male

Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation
Status: Completed Condition: Prostate Cancer

Courtesy of ClinicalTrials.org
See more clinical trials for this drug

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460Jun 14, 2010RXYes5,565,467<disabled>YY
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460Jun 14, 2010RXYes5,998,427<disabled>YYMETHOD OF TREATING AN ANDROGEN RESPONSE OR MEDIATED DISEASE IN A MAMMAL BY ADMININSTERING AN EFFECTIVE ANDROGEN RESPONSIVE OR MEDICATED DISEASE AMOUNT OF DUTASTERIDE..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERPLASIA
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460Jun 14, 2010RXYes5,846,976<disabled>METHOD OF TREATING ANDROGEN RESPONSIVE OR MEDICATED CONDITION IN A MAMMAL BY ADMINISTERING A SAFE & EFFECTIVE AMOUNT OF DUTASTERIDE OR A PHARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF.. CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
Anchen Pharms
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509Feb 26, 2014RXNo<disabled>
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