PERIACTIN

FDA-2026-P-6811 · 6 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 strengths of 2 mg, 3 mg, 4 mg, and 6 mg suitable for submission as an ANDA, wit

FDA-2026-P-5978 · 7 docket documents

The law firm Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Cyproheptadine HCL Tablets in 3 mg and 6 mg strengths suitable for submission as an Abbreviated New Drug Application, referen

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.