REVATIO

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

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

FDA-2014-P-1569 · 3 docket documents

Pharmacists Planning Service, Inc., a nonprofit public health organization, filed this citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue a federal regulation to reclassify Viagra (sildenafil citrate) from prescription-only status to a dual category allowing it

FDA-2009-P-0235 · 3 docket documents

Kleinfeld Kaplan and Becker LLP filed this citizen petition requesting that the FDA deny any new drug application or supplemental new drug application under Section 505(b)(1) for Pfizer's proposed intravenous formulation of sildenafil citrate (sildenafil IV) unless the application includes substanti

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