Helsinn Therapeutics U S Inc

FDA Filings

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

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Helsinn Therapeutics (U.S.), Inc.
Prescription Medication2023-12-30
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.
Prescription Medication2022-10-19
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
Helsinn Therapeutics (U.S.), Inc., Helsinn Advanced Synthesis SA, Pierre Fabre Medicament Production, Oso BioPharmaceutical Manufacturing, LLC, Helsinn Birex Pharmaceuticals Limited
Prescription Medication2022-07-22
Helsinn Therapeutics (U.S.), Inc.
Prescription Medication2022-07-14
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
Helsinn Therapeutics (U.S.), Inc.
Prescription Medication2021-03-04
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.
Prescription Medication2020-08-07
Helsinn Therapeutics (U.S.), Inc.
AKYNZEO2020-06-15
Helsinn Therapeutics (U.S.), Inc., Helsinn Healthcare SA, Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals LTD, Patheon Italia S.p.A.
Prescription Medication2020-06-15
Helsinn Therapeutics (U.S.), Inc., Catalent Pharma Solutions
Prescription Medication2020-04-16
Helsinn Therapeutics (U.S.), Inc., Helsinn Advanced Synthesis SA, Pierre Fabre Medicament Production, Oso BioPharmaceutical Manufacturing, LLC, Helsinn Birex Pharmaceuticals Limited
Prescription Medication2020-04-16
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.
Prescription Medication2020-01-21
Helsinn Therapeutics (U.S.), Inc.
Prescription Medication2018-11-10
Helsinn Therapeutics (U.S.), Inc.
VALCHLOR2018-11-08
Helsinn Therapeutics (U.S.), Inc., Helsinn Advanced Synthesis SA, Pierre Fabre Medicament Production, Oso BioPharmaceutical Manufacturing, LLC, Helsinn Birex Pharmaceuticals Limited
Prescription Medication2018-11-02
Helsinn Therapeutics (U.S.), Inc.
Aloxi2018-11-01
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
Helsinn Therapeutics (U.S.), Inc.
AKYNZEO2018-04-20
Helsinn Therapeutics (U.S.), Inc.
AKYNZEO2014-10-13
Helsinn Therapeutics (U.S.), Inc.
ALOXI2014-05-28

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