SILDENAFIL CITRATE | N203109 | VIATRIS SPECIALTY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2640 On behalf of a client, Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Sildenafil Tablets for Oral Suspension, 10 mg, suitable for submission in an ANDA, with REVATIO (sildenafil) Tablets | Suitability | 2026-03-13 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| M-287 | Jan 31, 2026 | Expired |