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CYPROHEPTADINE HYDROCHLORIDE

ANDA

CYPROHEPTADINE HYDROCHLORIDE | A087056 | HERITAGE PHARMA LABS INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma LLC FDA-2026-P-8559 · 10 docket documents Appco Pharma LLC filed a suitability petition regarding the regulatory pathway and approvability of a drug product, seeking FDA guidance on whether the proposed formulation and manufacturing process meet the agency's standards for approval under applicable regulatory mechanisms such as ANDA or NDA s	Suitability	2026-08-04	Open	Appco Pharma LLC

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#001 — 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.