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Details for New Drug Application (NDA): 203109

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NDA 203109 describes REVATIO, which is a drug marketed by Pfizer and is included in three NDAs. It is available from five suppliers. Additional details are available on the REVATIO profile page.

The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. There are thirty-three tentative approvals for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for NDA: 203109

Tradename:
REVATIO
Applicant:
Pfizer
Ingredient:
sildenafil citrate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203109

Suppliers and Packaging for NDA: 203109

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVATIO
sildenafil citrate
FOR SUSPENSION;ORAL 203109 NDA Pfizer Laboratories Div Pfizer Inc 0069-0336 0069-0336-21 1 BOTTLE in 1 CARTON (0069-0336-21) > 112 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 10MG BASE/ML
Approval Date:Aug 30, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 31, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN THERAPY
Regulatory Exclusivity Expiration:Aug 30, 2015
Regulatory Exclusivity Use:NEW DOSAGE FORM
Regulatory Exclusivity Expiration:Jan 31, 2017
Regulatory Exclusivity Use:NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS


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