Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5978

Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMay 27, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Jun 16, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Cyproheptadine HCL Tablets, 3 mg and 6 mg, are

suitable for submission as an ANDA

The Reference Listed Drug (RLD) upon which

this petition is based is Merck and Co., Inc.s

Data from Regulations.gov