Request that the FDA declare that the drug product, Fingolimod Oral Solution, 0.5 mg/5 mL and 15 mg/150 mL is suitable for submission in an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-6537

Request that the FDA declare that the drug product, Fingolimod Oral Solution, 0.5 mg/5 mL and 15 mg/150 mL is suitable for submission in an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensJun 8, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Jul 2, 2026	--

Keywords

CDER

Suitability Petition

Pharmobedient Consulting, LLC

declare that the drug product

Fingolimod Oral Solution, 0.5 mg/5 mL and

15 mg/150 mL is suitable for submission in an

Abbreviated New Drug Application (ANDA)

Reference Listed Drug (RLD)

Data from Regulations.gov