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, 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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