Requests that the FDA declare that Hydrocortisone Tablets, 2.5 mg, 7.5 mg, and 15 mg, are suitable for submission as an ANDA. As designated in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) the Reference Listed Drug (RLD) upon which this petition is based is Pharmacia & Upjohn Co.s (Pfizer, Inc.s) CORTEF (hydrocortisone) Tablets, which is approved for | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-1308

Requests that the FDA declare that Hydrocortisone Tablets, 2.5 mg, 7.5 mg, and 15 mg, are suitable for submission as an ANDA. As designated in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) the Reference Listed Drug (RLD) upon which this petition is based is Pharmacia & Upjohn Co.s (Pfizer, Inc.s) CORTEF (hydrocortisone) Tablets, which is approved for

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensFeb 5, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Feb 17, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

declare that Hydrocortisone Tablets

2.5 mg, 7.5 mg, and 15 mg

are suitable for submission as an ANDA

Approved Drug Products with

Therapeutic Equivalence Evaluations

Data from Regulations.gov