Requests that FDA declare that Apixaban Tablets for Oral Suspension, 2.5 mg, is suitable for submission in an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-0126

Requests that FDA declare that Apixaban Tablets for Oral Suspension, 2.5 mg, is suitable for submission in an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensJan 6, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Jun 8, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Apixaban Tablets for Oral Suspension, 2.5 mg,

is suitable for submission in an ANDA

the Reference Listed Drug (RLD) upon which

this petition is based is

Data from Regulations.gov