Requests that FDA declare that Estradiol Tablets, 0.25 mg and 0.75 mg, are suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2259

Requests that FDA declare that Estradiol Tablets, 0.25 mg and 0.75 mg, are suitable for submission as an ANDA

Documents

Comments

Description

Open

Comment Period OpensMar 4, 2026

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Hyman, Phelps & McNamara, P.C.	Mar 24, 2026	--

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Estradiol Tablets, 0.25 mg and 0.75 mg, are

suitable for submission as an ANDA

the Reference Listed Drug (RLD) upon which this

petition is based is Bristol-Myers Squibb Co.s