SILDENAFIL CITRATE | N203109 | VIATRIS SPECIALTY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2640 · 6 docket documents 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, Phelps & McNamara, P.C. |
Citizen Petition from Pharma Regulatory Consultants LLC FDA-2018-P-1174 · 6 docket documents Pharma Regulatory Consultants LLC filed this citizen petition on March 10, 2018, requesting that the FDA declare Sildenafil Citrate Oral Suspension, 10 mg/mL suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C), with the reference-listed drug being Revatio (Silde | Other | 2018-03-16 | Denied | Pharma Regulatory Consultants LLC |
Citizens Petition from Public Citizen's Health Research Group FDA-2005-P-0192 · 5 docket documents Public Citizen filed this citizen petition pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA immediately add black box warnings to the three phosphodiesterase-5 inhibitors Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil), as well as to Revatio (sild | Other | 2005-10-20 | Denied | Public Citizen's Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| M-287 | Jan 31, 2026 | Expired |