PERIACTIN

FDA-2026-P-6811 · 6 docket documents

Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg, 3 mg, 4 mg, and 6 mg strengths suitable for submission as an ANDA, with the reference listed drug being P

FDA-2026-P-5978 · 7 docket documents

Hyman, Phelps & McNamara, P.C. filed this suitability petition on behalf of a client under FDC Act Section 505(j)(2)(C) requesting that the FDA declare Cyproheptadine HCL Tablets in 3 mg and 6 mg strengths suitable for submission as an ANDA, with Merck's PERIACTIN (cyproheptadine HCL) Tablets 4 mg (

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.