CYPROHEPTADINE HYDROCHLORIDE

FDA-2026-P-8559 · 10 docket documents

Appco Pharma LLC filed a suitability petition with the FDA requesting a determination of whether diethylpropion is suitable for inclusion in an abbreviated new drug application for a controlled-release formulation. The petitioner seeks confirmation that the agency would accept an ANDA for diethylpro

FDA-2026-P-6811 · 6 docket documents

Senores Pharmaceuticals, Inc. filed a petition requesting FDA determination that their proposed drug product is suitable for abbreviated new drug application (ANDA) review, which involves establishing bioequivalence to a reference product and seeking approval to market a generic version through the

FDA-2026-P-5978 · 8 docket documents

Hyman, Phelps & McNamara, P.C. filed a suitability petition requesting that the FDA determine the regulatory suitability of a proposed product or manufacturing process, though the specific drug name and requested action are not detailed in the provided document excerpt.

FDA-2025-P-1278 · 14 docket documents

Senores Pharmaceuticals, Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg and 4 mg strengths suitable for submission as an ANDA, with the reference

FDA-2024-P-4601 · 8 docket documents

Pharmobedient Consulting, LLC filed a suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Cyproheptadine Hydrochloride Tablets in 2 mg strength, which differs from the Reference Li