Genzyme L T D

FDA Filings

This page includes the latest FDA filings for Genzyme L T D. 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
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2025-09-24
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2025-08-21
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2025-07-12
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2025-05-23
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2025-01-12
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2025-01-01
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2024-12-13
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2024-07-31
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2024-07-16
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2024-05-22
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2024-04-20
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2024-04-06
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2024-03-19
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2024-02-24
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2024-01-13
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
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2023-11-17
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2023-11-10
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2023-10-19
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2023-10-07
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2023-07-27
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2023-06-27
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2023-05-26
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2023-05-26
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2023-05-12
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2023-05-05
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2023-01-19
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2023-01-12
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
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2022-12-17
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2022-11-22
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2022-11-03
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2022-11-01
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2022-10-01
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2022-08-25
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2022-07-30
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2022-06-03
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2022-06-03
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2022-05-26
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2022-05-03
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2022-04-07
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2022-01-22
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2022-01-05
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2021-12-07
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2021-11-20
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2021-08-25
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2021-08-17
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2021-08-17
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2021-08-04
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2021-07-16
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2021-07-14
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2021-07-14
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2021-07-14
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
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2021-05-22
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2021-05-08
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2021-05-07
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2021-04-09
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2021-03-31
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2021-03-12
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2021-03-02
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2021-01-30
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2020-12-12
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2020-12-10
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2020-12-02
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2020-10-17
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 Medication2020-10-16
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2020-10-06
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2020-08-25
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2020-07-09
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2020-06-23
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2020-06-04
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2020-05-14
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2020-04-01
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2020-02-27
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2020-02-22
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
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., 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
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2019-12-05
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2019-11-20
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2019-11-06
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Pharmachem Testing Services, Ash Stevens Inc., Genzyme Limited, Genzyme Corporation
Prescription Medication2019-10-25
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
Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation
Prescription Medication2019-10-25
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2019-08-08
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2019-06-18
Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited
Prescription Medication2019-06-07
sanofi-aventis U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation
Prescription Medication2019-06-07
Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc.
Prescription Medication2019-03-22
Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED
Prescription Medication2018-12-15
Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED
Prescription Medication2018-11-30
Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc.
Prescription Medication2018-04-20

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