Helsinn Healthcare S A

FDA Filings

This page includes the latest FDA filings for Helsinn Healthcare S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004642655
FEI Number3004642653
NameJason Najdzinowicz
Owner & OperatorHelsinn Healthcare SA
Contact AddressP.O. Box 357
Pambio Noranco (Lugano) CH-TI Ticino 6915 CH
Official Correspondent
  • Maddalena Maggionami
  • 41-91-985-2121
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address170 Wood Ave. South 5th Floor
Iselin, NJ 08830 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2023-12-05
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2023-08-01
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2023-03-06
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2022-08-27
QED Therapeutics, Inc., Helsinn Healthcare SA
Prescription Medication2022-02-11
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2021-11-17
QED Therapeutics, Inc., Helsinn Healthcare SA
Prescription Medication2021-06-04
QED Therapeutics, Inc., Helsinn Healthcare SA
Prescription Medication2021-06-03
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2020-11-24
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2020-06-15
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2020-03-27
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2018-05-04
Jason Najdzinowicz [Helsinn Healthcare SA]
Xonrid?2017-01-13
Helsinn Healthcare SA
Xonrid Gel2016-10-28
Jason Najdzinowicz [Helsinn Healthcare SA]
Gelclair?2009-10-19
Jason Najdzinowicz [Helsinn Healthcare SA]
Gelclair?2009-10-19

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020072852323Genova,Italy -> New York/Newark Area, Newark, New JerseyMEDICAMENTS GELCLAIR1602 PKG
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