Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-6024

Requests that FDA declare that Clemastine Fumarate Oral Syrup, 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL, is suitable for submission in an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensNov 12, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response	May 15, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Clemastine Fumarate Oral Syrup,

0.25 mg base/5 mL, 0.75 mg base/5 mL, and

1 mg base/5 mL, is suitable for submission

in an ANDA. The Reference Listed Drug (RLD) upon

Data from Regulations.gov