Winthrop U S A Business Of Sanofi Aventis U S L L C

FDA Filings

This page includes the latest FDA filings for Winthrop U S A Business Of Sanofi Aventis U S L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
Insulin glargine U-300 Max Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2025-07-02
Enoxaparin sodium 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 Medication	2025-07-02
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2025-06-13
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2024-12-10
Zolpidem Tartrate Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga	Prescription Medication	2024-12-08
Insulin glargine U-300 Max Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2024-09-13
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2024-07-23
Insulin Glargine Solostar Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.	Prescription Medication	2024-01-04
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2023-12-08
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2023-12-08
Insulin glargine U-300 Max Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2023-12-08
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2023-12-08
Clofarabine 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 Medication	2023-12-08
OXALIPLATIN Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.	Prescription Medication	2023-12-08
Zolpidem Tartrate Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga	Prescription Medication	2023-12-08
Insulin Glargine Solostar Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.	Prescription Medication	2023-12-08
Enoxaparin sodium 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 Medication	2023-12-08
Insulin Glargine Solostar Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.	Prescription Medication	2023-12-01
OXALIPLATIN Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.	Prescription Medication	2023-07-13
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2023-06-16
Doxercalciferol 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 Medication	2023-04-29
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2023-04-06
Insulin glargine U-300 Max Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2023-02-01
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2023-01-29
Insulin glargine U-300 Max Winthrop U.S, a business of sanofi-aventis U.S. LLC, Genzyme Corporation, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2023-01-18
Doxercalciferol 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 Medication	2023-01-07
Clofarabine 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 Medication	2022-12-21
Insulin Glargine Solostar Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.	Prescription Medication	2022-11-03
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2022-06-24
Zolpidem Tartrate Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga	Prescription Medication	2022-06-19
Insulin Glargine Solostar Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l.	Prescription Medication	2022-05-02
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2022-04-28
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2022-01-25
Enoxaparin sodium 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 Medication	2022-01-12
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2021-12-30
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2021-12-16
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2021-11-24
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2021-11-17
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2021-10-02
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2021-08-26
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2021-06-04
Clofarabine 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 Medication	2021-05-27
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2021-05-21
Enoxaparin sodium 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 Medication	2021-04-13
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2021-01-14
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2021-01-05
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2020-12-24
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2020-12-03
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2020-11-21
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2020-10-16
Clofarabine 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 Medication	2020-10-16
Zolpidem Tartrate Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga	Prescription Medication	2020-09-03
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2020-05-23
Enoxaparin sodium 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 Medication	2020-05-14
OXALIPLATIN Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.	Prescription Medication	2020-05-06
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2020-03-27
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2020-01-03
Clofarabine 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 Medication	2020-01-03
Clofarabine 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 Medication	2019-10-25
Doxercalciferol 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 Medication	2019-10-15
OXALIPLATIN Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Johnson Matthey Inc.	Prescription Medication	2019-10-04
Zolpidem Tartrate Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi Chimie, Sanofi Winthrop Industrie, Finorga	Prescription Medication	2019-09-10
Irbesartan Winthrop U.S, a business of sanofi-aventis U.S. LLC, Eurofins Lancaster Laboratories, Inc, Sanofi Chimie, EUROAPI Hungary Ltd., Sanofi Winthrop Industrie	Prescription Medication	2019-09-03
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2019-08-27
Doxercalciferol 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 Medication	2019-08-27
Enoxaparin sodium 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 Medication	2019-07-16
Doxercalciferol 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 Medication	2019-07-13
Docetaxel Winthrop U.S, a business of sanofi-aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, Sanofi Chimie	Prescription Medication	2019-06-18
Enoxaparin sodium 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 Medication	2019-05-14
NDC 0955-1048 Winthrop U.S, a business of sanofi-aventis U.S. LLC	Sevelamer Hydrochloride	2019-02-13
Leflunomide Winthrop U.S., OPELLA HEALTHCARE INTERNATIONAL SAS, Sanofi-Aventis Deutschland GmbH	Prescription Medication	2018-11-09
NDC 0955-1722 Winthrop U.S, a business of sanofi-aventis U.S. LLC	Doxercalciferol	2017-04-17
NDC 0955-1721 Winthrop U.S, a business of sanofi-aventis U.S. LLC	Doxercalciferol	2017-04-17
NDC 0955-1720 Winthrop U.S, a business of sanofi-aventis U.S. LLC	Doxercalciferol	2017-04-17
NDC 0955-1703 Winthrop U.S, a business of sanofi-aventis U.S. LLC	Zolpidem Tartrate	2010-12-06
NDC 0955-1702 Winthrop U.S, a business of sanofi-aventis U.S. LLC	Zolpidem Tartrate	2010-10-14

Similar & Related FDA Registered Companies

• Aventis Pharma Manufacturing Pte. Ltd.
• Sanofi Winthrop Industrie
• Genzyme Corporation
• Sanofi-Aventis Deutschland GmbH
• Winthrop U.S.
• OPELLA HEALTHCARE INTERNATIONAL SAS
• Sanofi Chimie
• Finorga
• Sanofi S.r.l.
• Pharmachemie B.V.
• Pfanstiehl, Inc.
• Mayne Pharma International Pty Ltd.
• Ash Stevens Inc.
• EUROAPI UK LIMITED
• Eurofins Lancaster Laboratories, Inc
• EUROAPI Hungary Ltd.
• Johnson Matthey Inc.
• Catalent Pharma Solutions, LLC
• AndersonBrecon Inc.
• Assia Chemical Industries Ltd. - Teva Tech Site
• Genzyme Ireland Limited