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Profile for Tradename: AVODART

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Avodart is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in AVODART is dutasteride. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the dutasteride profile page.

Summary for Tradename: AVODART

Suppliers: see list3

Pharmacology for Tradename: AVODART

Clinical Trials for: AVODART

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

Bioequivalence - Duodart Against Avodart & Omnic
Status: Completed Condition: Prostatic Hyperplasia

AVODARTĀ® Alopecia Post-marketing Surveillance (PMS)
Status: Completed Condition: Alopecia

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

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

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

ARTS - AVODART After Radical Therapy For Prostate Cancer Study
Status: Completed Condition: Neoplasms, Prostate; Prostate Cancer After a Radical Treatment

Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
Status: Completed Condition: Androgenetic Alopecia

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL021319Nov 20, 2001RXYes5,846,976<disabled><disabled>
CAPSULE;ORAL021319Nov 20, 2001RXYes5,998,427<disabled>YY<disabled>
CAPSULE;ORAL021319Nov 20, 2001RXYes5,565,467<disabled>YY<disabled>
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Paragraph IV activity for: AVODART

Drugname Dosage Strength RLD Submissiondate
dutasterideCapsules0.5 mgAvodart10/29/2007
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