Winthrop U S

FDA Filings

This page includes the latest FDA filings for Winthrop U S. 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
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2025-02-13
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2024-12-10
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga
Prescription Medication2024-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2024-09-13
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2024-07-31
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2024-07-23
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.
Prescription Medication2024-01-04
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2023-12-08
Winthrop U.S., Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga
Prescription Medication2023-12-08
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.
Prescription Medication2023-12-08
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Aventis Pharma Manufacturing Pte. Ltd., Sanofi Winthrop Industrie, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2023-12-08
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.
Prescription Medication2023-12-01
Winthrop U.S., Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2023-09-08
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2023-08-17
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2023-07-31
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2023-07-26
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2023-07-14
Winthrop U.S., Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2023-07-13
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2023-07-13
Winthrop U.S., Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2023-06-23
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2023-06-16
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Catalent Pharma Solutions, LLC, AndersonBrecon Inc., Assia Chemical Industries Ltd. - Teva Tech Site, Genzyme Ireland Limited
Prescription Medication2023-04-29
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2023-04-06
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2023-02-01
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2023-01-29
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2023-01-18
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Catalent Pharma Solutions, LLC, AndersonBrecon Inc., Assia Chemical Industries Ltd. - Teva Tech Site, Genzyme Ireland Limited
Prescription Medication2023-01-07
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2022-12-21
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2022-12-17
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2022-11-19
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.
Prescription Medication2022-11-03
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2022-06-24
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga
Prescription Medication2022-06-19
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.
Prescription Medication2022-05-02
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2022-04-28
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2022-01-25
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Aventis Pharma Manufacturing Pte. Ltd., Sanofi Winthrop Industrie, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2022-01-12
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2021-12-30
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2021-12-16
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2021-11-24
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2021-11-18
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2021-11-17
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2021-10-02
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2021-10-02
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2021-08-26
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2021-07-16
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2021-07-16
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2021-06-04
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2021-05-27
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2021-05-21
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2021-05-21
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2021-05-07
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2021-05-07
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Aventis Pharma Manufacturing Pte. Ltd., Sanofi Winthrop Industrie, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2021-04-13
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2021-01-14
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2021-01-13
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2021-01-07
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2021-01-05
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2020-12-24
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2020-12-03
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2020-11-21
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2020-10-16
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2020-10-16
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga
Prescription Medication2020-09-03
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2020-09-01
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2020-06-09
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2020-05-23
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2020-05-14
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2020-05-14
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Aventis Pharma Manufacturing Pte. Ltd., Sanofi Winthrop Industrie, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2020-05-14
Winthrop U.S., Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2020-05-06
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2020-05-06
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2020-03-27
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2020-01-03
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2020-01-03
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2019-12-17
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2019-10-25
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Catalent Pharma Solutions, LLC, AndersonBrecon Inc., Assia Chemical Industries Ltd. - Teva Tech Site, Genzyme Ireland Limited
Prescription Medication2019-10-15
Winthrop U.S., Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2019-10-04
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.
Prescription Medication2019-10-04
Winthrop U.S.
Irbesartan2019-09-30
Winthrop U.S.
Irbesartan2019-09-30
Winthrop U.S.
Irbesartan2019-09-30
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga
Prescription Medication2019-09-10
Winthrop U.S.
Irbesartan And Hydrochlorothiazide2019-09-03
Winthrop U.S.
Irbesartan And Hydrochlorothiazide2019-09-03
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie
Prescription Medication2019-09-03
Winthrop U.S., Sanofi Chimie, EUROAPI Hungary Ltd., Eurofins Lancaster Laboratories, Inc, CAMBREX PROFARMACO MILANO S.R.L., Sanofi Winthrop Industrie
Prescription Medication2019-09-03
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2019-08-27
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Catalent Pharma Solutions, LLC, AndersonBrecon Inc., Assia Chemical Industries Ltd. - Teva Tech Site, Genzyme Ireland Limited
Prescription Medication2019-08-27
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Aventis Pharma Manufacturing Pte. Ltd., Sanofi Winthrop Industrie, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2019-07-16
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Catalent Pharma Solutions, LLC, AndersonBrecon Inc., Assia Chemical Industries Ltd. - Teva Tech Site, Genzyme Ireland Limited
Prescription Medication2019-07-13
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie
Prescription Medication2019-06-18
Winthrop U.S, a business of sanofi-aventis U.S. LLC, Aventis Pharma Manufacturing Pte. Ltd., Sanofi Winthrop Industrie, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH
Prescription Medication2019-05-14
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2019-03-22
Winthrop U.S.
Sevelamer Hydrochloride2019-02-13
Winthrop U.S, a business of sanofi-aventis U.S. LLC, OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH
Prescription Medication2018-11-09
Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA
Prescription Medication2018-10-20
Winthrop U.S.
Sevelamer Carbonate2018-02-01
Winthrop U.S.
Sevelamer Carbonate2018-01-01
Winthrop U.S.
Sevelamer Carbonate2018-01-01
Winthrop U.S.
Clofarabine2017-05-11
Winthrop U.S.
Doxercalciferol2017-04-17
Winthrop U.S.
Doxercalciferol2017-04-17
Winthrop U.S.
Doxercalciferol2017-04-17
Winthrop U.S.
Docetaxel2016-10-23
Winthrop U.S.
Leflunomide2015-09-07
Winthrop U.S.
Leflunomide2015-09-07
Winthrop U.S.
OXALIPLATIN2015-09-01
Winthrop U.S.
OXALIPLATIN2015-09-01
Winthrop U.S.
OXALIPLATIN2014-07-07
Winthrop U.S.
OXALIPLATIN2014-07-07
Winthrop U.S.
Desipramine Hydrochloride2014-04-01
Winthrop U.S.
Methenamine Hippurate2012-01-23
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Enoxaparin Sodium2011-10-03
Winthrop U.S.
Zolpidem Tartrate2010-12-06
Winthrop U.S.
Docetaxel2010-10-21
Winthrop U.S.
Docetaxel2010-10-21
Winthrop U.S.
Zolpidem Tartrate2010-10-14

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