PERIACTIN

FDA-2026-P-8559 · 10 docket documents

Appco Pharma LLC filed a suitability petition regarding the regulatory pathway and approvability of a drug product, seeking FDA guidance on whether the proposed formulation and manufacturing process meet the agency's standards for approval under applicable regulatory mechanisms such as ANDA or NDA s

FDA-2026-P-6811 · 6 docket documents

Senores Pharmaceuticals, Inc. filed a suitability petition requesting FDA guidance on whether an abbreviated new drug application (ANDA) can be submitted for a generic version of a brand-name drug product. The petition seeks clarification on regulatory pathways and requirements for demonstrating bio

FDA-2026-P-5978 · 7 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-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

FDA-2018-P-3426 · 4 docket documents

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 · 6 docket documents

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.