PERIACTIN

FDA-2026-P-6811

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-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 a reference li

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.