Requests that FDA declare that Sildenafil Tablets for Oral Suspension, 10 mg, is suitable for submission in an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2640

Requests that FDA declare that Sildenafil Tablets for Oral Suspension, 10 mg, is suitable for submission in an ANDA

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMar 13, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Hyman, Phelps & McNamara, P.C.	Mar 31, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Sildenafil Tablets for Oral Suspension, 10 mg,

is suitable for submission in an ANDA

The Reference Listed Drug (RLD)

upon which this petition is based is

Data from Regulations.gov