Request that the FDA determine and declare that Dapagliflozin Tablets 7.5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7623

Request that the FDA determine and declare that Dapagliflozin Tablets 7.5 mg is suitable for submission in an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensJul 9, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Senores Pharmaceuticals, Inc.	Jul 30, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals, Inc

determine and declare that

Dapagliflozin Tablets 7.5 mg

is suitable for submission in an

Abbreviated New Drug Application (ANDA)

OPEN

Data from Regulations.gov