Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Dabrafenib Capsules 150 mg strength | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-7322

Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Dabrafenib Capsules 150 mg strength

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 23, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Rising Pharma Holdings, Inc.	May 19, 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 Dabrafenib Capsules 150 mg strength

CLOSED

Data from Regulations.gov