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Details for Generic Name: sildenafil citrate

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Sildenafil citrate is the generic ingredient in three branded drugs marketed by Pfizer, Actavis Grp Ptc, Amneal Pharms, Apotex Corp, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan Pharms Inc, Teva Pharms, Torrent Pharms Ltd, Watson Labs Inc, and Pfizer Ireland, and is included in fourteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for sildenafil citrate. Twelve suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for Generic Name: sildenafil citrate

Drug Master File Entries: see list19
Suppliers: see list12
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: sildenafil citrate

Tentative approvals for SILDENAFIL CITRATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL25MG
<disabled><disabled>TABLET; ORAL50MG
<disabled><disabled>TABLET; ORAL100MG

Clinical Trials for: sildenafil citrate

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

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: Recruiting Condition: Subarachnoid Hemorrhage; Cerebral Vasospasm; Rupture of Intracranial Aneurysm

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

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms Ltd
sildenafil citrate
TABLET;ORAL091479Nov 6, 2012RXNo<disabled><disabled>
sildenafil citrate
SOLUTION;INTRAVENOUS022473Nov 18, 2009RXYes<disabled><disabled>
sildenafil citrate
TABLET;ORAL021845Jun 3, 2005RXYes<disabled><disabled>
Pfizer Ireland
sildenafil citrate
TABLET;ORAL020895Mar 27, 1998RXNo6,469,012*PED<disabled>Y<disabled>
sildenafil citrate
TABLET;ORAL021845Jun 3, 2005RXYes<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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