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CYPROHEPTADINE HYDROCHLORIDE

ANDA

CYPROHEPTADINE HYDROCHLORIDE | A086833 | ACTAVIS MID ATLANTIC LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 Senores Pharmaceuticals, Inc. filed an amendment to an ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to develop Cyproheptadine Hydrochloride orally disintegrating tablets in 2 mg and 4 mg strengths, based on the reference lis	Suitability	2025-12-09	Open	Senores Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPACYPROHEPTADINE HYDROCHLORIDE

DMF 32931978

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveCYPROHEPTADINE HYDROCHLORIDE

DMF 173642004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.