PERIACTIN

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-2025-P-1278

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-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.