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Profile for Tradename: REVATIO

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Revatio is a drug marketed by Pfizer and is included in three NDAs. It is available from five suppliers.

The generic ingredient in REVATIO is sildenafil citrate. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for Tradename: REVATIO

Suppliers: see list5

Pharmacology for Tradename: REVATIO

Clinical Trials for: REVATIO

A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
Status: Completed Condition: Pulmonary Arterial Hypertention

Sildenafil in Single Ventricle Patients
Status: Completed Condition: Heart Disease

Pharmacokinetics of Sildenafil in Premature Infants
Status: Recruiting Condition: Persistent Pulmonary Hypertension of the Newborn

Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy
Status: Suspended Condition: Duchenne Muscular Dystrophy; Becker Muscular Dystrophy

Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles
Status: Completed Condition: Endometrial Preparation; Frozen Embryo Transfer

Effects of Viagra on Heart Function in Patients With Heart Failure
Status: Completed Condition: Heart Failure; Left Ventricular Dysfunction

Sildenafil for Prevention of Cerebral Vasospasm
Status: Withdrawn Condition: Subarachnoid Hemorrhage; Cerebral Vasospasm; Rupture of Intracranial Aneurysm

VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
Status: Recruiting Condition: Pulmonary Hypertension Associated With Connective Tissue Disease

A Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery
Status: Recruiting Condition: Acute Kidney Injury

Effects of Oral Sildenafil on Mortality in Adults With PAH
Status: Recruiting Condition: Pulmonary Arterial Hypertension

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
sildenafil citrate
FOR SUSPENSION;ORAL203109-001Aug 30, 2012RXYes<disabled><disabled>
sildenafil citrate
SOLUTION;INTRAVENOUS022473-001Nov 18, 2009RXYes<disabled><disabled>
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 2005RXYes<disabled><disabled>
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 2005RXYes<disabled><disabled>
sildenafil citrate
FOR SUSPENSION;ORAL203109-001Aug 30, 2012RXYes<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

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

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