Details for New Drug Application (NDA): 203109
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The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 203109
Tradename: | REVATIO |
Applicant: | Viatris |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203109
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 203109
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Aug 30, 2012 | TE: | AB | RLD: | 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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