CYPROHEPTADINE HYDROCHLORIDE

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-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