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Details for Generic Name: finasteride

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Summary for Generic Name: finasteride

Drug Master File Entries: see list13
Suppliers: see list3
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)

Pharmacology for Ingredient: finasteride

Tentative approvals for FINASTERIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL1MG

Clinical Trials for: finasteride

An Observational Registry-Based Study of a Potential Link Between Finasteride (MK-0906) and Male Breast Cancer in 4 Nordic Countries (MK-0906-162/2003.021)
Status: Active, not recruiting Condition: Male Breast Cancer

3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy
Status: Completed Condition: Enlarged Prostate

Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions
Status: Completed Condition: Healthy

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
TABLET;ORAL020788Dec 19, 1997RXYes5,571,817<disabled><disabled>
Sun Pharma Global
TABLET;ORAL090508Jul 1, 2013RXNo<disabled><disabled>
TABLET;ORAL076511Dec 15, 2006RXNo<disabled><disabled>
TABLET;ORAL020788Dec 19, 1997RXYes5,547,957<disabled><disabled>
Dr Reddys Labs Inc
TABLET;ORAL076436Jul 28, 2006RXNo<disabled><disabled>
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