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CYPROHEPTADINE HYDROCHLORIDE

ANDA

CYPROHEPTADINE HYDROCHLORIDE | A040644 | KENTON CHEMICALS AND PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pharmax Group, Inc FDA-2018-P-3426 Pharmax Group, Inc. filed this citizen petition requesting that the FDA designate Santos Biotech Industries Inc. as an alternate reference standard for Cyproheptadine Hydrochloride Tablets, USP 4 mg (ANDA #A040644) because the current reference standard held by IVAX Pharmaceuticals Inc. Sub Teva Pha	505(q)	2018-09-11	Granted	Pharmax Group

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

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 30, 2006

No patent or exclusivity listings for this strength.