PERIACTIN

FDA-2026-P-8559

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

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

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-2024-P-4601

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

FDA-2018-P-3426

Pharmax Group, Inc. filed this citizen petition requesting that the FDA designate Santos Biotech Industries Inc. as an alternate reference standard for Cyproheptadine Hydrochloride Tablets, USP 4 mg (ANDA #A040644) because the current reference standard held by IVAX Pharmaceuticals Inc. Sub Teva Pha

FDA-2002-P-0001

CorePharma LLC requests that the FDA assign reference listed drug status to a currently marketed and approved Cyproheptadine Hydrochloride Tablets 4 mg product, asserting that Merck's Periactin, the existing RLD, is no longer available in the market as evidenced by Merck's discontinuation notice.