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Details for Generic Name: silodosin

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Silodosin is the generic ingredient in one branded drug marketed by Actavis Labs Ut Inc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for silodosin. Two suppliers are listed for this compound.

Summary for Generic Name: silodosin

Drug Master File Entries: see list5
Suppliers: see list2

Pharmacology for Ingredient: silodosin

Clinical Trials for: silodosin

Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Status: Completed Condition: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Silodosin Versus Tamsulosin for Treatment of Ureteral Stones
Status: Terminated Condition: Ureteral Calculus; Ureterolithiasis; Ureteral Stone

Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH
Status: Completed Condition: Benign Prostatic Hypertrophy

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia
Status: Completed Condition: Benign Prostatic Hyperplasia

Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)
Status: Completed Condition: Benign Prostatic Hyperplasia

Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
Status: Recruiting Condition: Nocturia; Benign Prostatic Hyperplasia

Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder
Status: Completed Condition: Neurogenic Bladder; Voiding Dysfunction

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Status: Completed Condition: Nocturia; Prostatic Hyperplasia

A Dose-finding Study of Silodosin in Patients With Urinary Calculi
Status: Completed Condition: Urinary Calculus

Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy
Status: Not yet recruiting Condition: Urinary Problems; Prostate Cancer

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
Actavis Labs Ut Inc
CAPSULE;ORAL022206-002Oct 8, 2008RXNo5,387,603<disabled>YY<disabled>
Actavis Labs Ut Inc
CAPSULE;ORAL022206-001Oct 8, 2008RXYes5,387,603<disabled>YY<disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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