Request that the FDA declare that Dapagliflozin Chewable Tablets, 5 mg and 10 mg, are suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4020

Request that the FDA declare that Dapagliflozin Chewable Tablets, 5 mg and 10 mg, are suitable for submission as an ANDA

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensApr 13, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Suitability Petition from Hyman, Phelps & McNamara, P.C.	Apr 13, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

declare that Dapagliflozin Chewable Tablets

5 mg and 10 mg, are suitable

for submission as an ANDA

OPEN

Data from Regulations.gov