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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021845


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NDA 021845 describes REVATIO, which is a drug marketed by Viatris and is included in three NDAs. It is available from three 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. Sixty-three suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 021845
Tradename:REVATIO
Applicant:Viatris
Ingredient:sildenafil citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021845
Mechanism of ActionPhosphodiesterase 5 Inhibitors
Medical Subject Heading (MeSH) Categories for 021845
Suppliers and Packaging for NDA: 021845
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVATIO sildenafil citrate TABLET;ORAL 021845 NDA PFIZER LABORATORIES DIV PFIZER INC 0069-4190 0069-4190-68 90 TABLET, FILM COATED in 1 BOTTLE (0069-4190-68)
REVATIO sildenafil citrate TABLET;ORAL 021845 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-345 43353-345-10 10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jun 3, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 31, 2026
Regulatory Exclusivity Use:LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17)

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