Details for New Drug Application (NDA): 203109
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NDA 203109 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-eight suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-eight suppliers are listed 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 |
Pharmacology for NDA: 203109
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 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 |
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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