CYPROHEPTADINE HYDROCHLORIDE | N013220 | MERCK AND CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-6811 · 6 docket documents 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 | Suitability | 2026-06-16 | Open | Senores Pharmaceuticals, Inc. |
Suitability Petition from Senores Pharmaceuticals, Inc. 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 | Suitability | 2025-05-16 | Granted | Senores Pharmaceuticals, Inc. |
Citizen Petition from CorePharma, LLC 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. | 505(q) | 2014-09-29 | Denied | CorePharma, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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