Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, USP 0.8 mg | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-3630

Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, USP 0.8 mg

Documents

Comments

Description

Open

Key Dates

Comment Period OpensApr 2, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Attachment 1	Apr 2, 2026	--

Keywords

CDER

Suitability Petition

Rising Pharma Holdings, Inc.

Requests that the FDA issue a declaration

permitting the submission of an

Abbreviated New Drug Application (ANDA) for

Tamsulosin Hydrochloride Capsules, USP 0.8 mg

Open

Data from Regulations.gov