Requests that the FDA declare that Cyproheptadine Hydrochloride Orally Disintegrating Tablets, 2 mg, 3 mg, 4 mg and 6 mg is suitable for submission as an ANDA. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-6811

Requests that the FDA declare that Cyproheptadine Hydrochloride Orally Disintegrating Tablets, 2 mg, 3 mg, 4 mg and 6 mg is suitable for submission as an ANDA.

Documents

Comments

Key Dates

Comment Period OpensJun 16, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Suitability Petition from Senores Pharmaceuticals, Inc.	Jun 16, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals Inc

declare that Cyproheptadine

Hydrochloride Orally Disintegrating Tablets

2 mg 3 mg 4 mg and 6 mg

is suitable for submission as an ANDA

OPEN

Data from Regulations.gov