Amgen Inc

FDA Filings

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

USANASDAQAMGNDUNS 039976196

Amgen Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Amgen Inc
Prescription Medication2025-10-02
Amgen Inc
Prescription Medication2025-09-24
Amgen Inc
Prescription Medication2025-09-19
Amgen Inc, Amgen, Inc
Prescription Medication2025-09-17
Amgen Inc
Prescription Medication2025-09-14
Amgen Inc, BioReliance Corporation
Prescription Medication2025-09-14
Amgen Inc, BioReliance Corporation
Prescription Medication2025-09-07
Amgen USA Inc., Amgen, Inc
Prescription Medication2025-09-06
Amgen Inc
Prescription Medication2025-08-31
Amgen Inc, Amgen, Inc
Prescription Medication2025-08-01
Amgen, Inc, Amgen Europe BV
Prescription Medication2025-07-19
Amgen Inc, BioReliance Corporation
Prescription Medication2025-06-30
Amgen Inc, Amgen Manufacturing Ltd, Amgen Technology (ireland) Unlimited Company, Amgen, Inc, BioReliance Corporation
Prescription Medication2025-06-30
Amgen Inc
Prescription Medication2025-06-30
Amgen Inc, Amgen, Inc
Prescription Medication2025-06-25
Amgen Inc
Prescription Medication2025-06-22
Amgen Inc, Patheon Manufacturing Services LLC, PPD Development, LP. (Middleton, WI Laboratory)
Prescription Medication2025-06-22
Amgen Inc
Prescription Medication2025-06-22
Amgen, Inc
Prescription Medication2025-06-20
Amgen Inc, Immunex Rhode Island Corporation, Patheon Italia S.p.A.
Prescription Medication2025-06-18
Amgen, Inc, Amgen Europe BV
Prescription Medication2025-06-17
Amgen, Inc, Amgen Manufacturing Limited LLC
Prescription Medication2025-06-17
Amgen Inc
Prescription Medication2025-06-13
Amgen Inc
Prescription Medication2025-06-07
Amgen USA Inc., Amgen, Inc
Prescription Medication2025-05-24
Amgen Inc
Prescription Medication2025-05-15
Amgen Inc
Prescription Medication2025-05-11
Amgen Inc
Prescription Medication2025-05-10
Amgen, Inc, Amgen Manufacturing Limited LLC
Prescription Medication2025-05-03
Amgen Inc, Amgen Manufacturing Ltd, Amgen, Inc, Patheon Manufacturing Services LLC
Prescription Medication2025-04-25
Amgen Inc
Prescription Medication2025-04-24
Amgen Inc
Prescription Medication2025-04-19
Amgen Inc, Amgen Manufacturing Ltd
Prescription Medication2025-04-18
Amgen Inc, West Pharmaceutical Services, Inc.
Prescription Medication2025-04-18
Janssen Products, LP, Amgen Manufacturing Ltd, Patheon Manufacturing Services LLC, Amgen, Inc.
Prescription Medication2025-04-10
Amgen Inc, Amgen Manufacturing Ltd, Amgen Technology (ireland) Unlimited Company, Amgen, Inc, BioReliance Corporation
Prescription Medication2025-04-06
Optum Health Solutions (Ireland) Limited, Amgen, Inc
Prescription Medication2025-04-03
Amgen, Inc, Amgen Singapore Manufacturing Pte. Ltd.
Prescription Medication2025-03-09
Amgen Inc, Immunex Rhode Island Corporation, Patheon Italia S.p.A.
Prescription Medication2025-03-09
Amgen USA Inc., Amgen, Inc
Prescription Medication2025-03-02
Amgen Inc, Amgen Singapore Manufacturing Pte. Ltd., Amgen Technology (ireland) Unlimited Company, Amgen Manufacturing Ltd
Prescription Medication2025-03-02
Optum Health Solutions (Ireland) Limited, Amgen, Inc
Prescription Medication2025-02-09
Amgen, Inc, Amgen Europe BV
Prescription Medication2025-02-05
Amgen Inc
Prescription Medication2025-01-30
Amgen Inc, Amgen, Inc
Prescription Medication2025-01-30
Amgen Inc
Prescription Medication2025-01-01
Optum Health Solutions (Ireland) Limited, Amgen, Inc
Prescription Medication2025-01-01
Amgen Inc
Prescription Medication2024-12-22
Amgen Inc, Amgen, Inc
Prescription Medication2024-12-18
Amgen USA Inc., Amgen, Inc
Prescription Medication2024-12-06
Amgen Inc, Amgen Manufacturing Ltd
Prescription Medication2024-11-15
Amgen Inc, Amgen, Inc
Prescription Medication2024-11-15
Amgen Inc, Immunex Rhode Island Corporation, Patheon Italia S.p.A.
Prescription Medication2024-11-15
Amgen, Inc, Amgen Manufacturing Limited LLC
Prescription Medication2024-11-15
Amgen Inc
Prescription Medication2024-11-15
Amgen Inc, Patheon Inc.
Prescription Medication2024-11-15
Amgen Inc, BioReliance Corporation
Prescription Medication2024-11-14
Amgen Inc
Prescription Medication2024-11-14
Amgen, Inc, Amgen Singapore Manufacturing Pte. Ltd.
Prescription Medication2024-11-01
Amgen Inc, Amgen, Inc
Prescription Medication2024-10-13
Optum Health Solutions (Ireland) Limited, Amgen, Inc
Prescription Medication2024-09-26
Amgen Inc
Prescription Medication2024-09-05
Amgen USA Inc., Amgen, Inc
Prescription Medication2024-09-04
Amgen Inc, Amgen Europe BV, Amgen Manufacturing Ltd, Amgen Technology (ireland) Unlimited Company, Immunex Rhode Island Corporation
Prescription Medication2024-09-04
Amgen Inc, Amgen Manufacturing Ltd, Amgen Technology (ireland) Unlimited Company, Amgen, Inc, BioReliance Corporation
Prescription Medication2024-08-17
Amgen Inc
Prescription Medication2024-07-23
Amgen Inc, Amgen, Inc
Prescription Medication2024-07-18
Amgen Inc, Amgen, Inc
Prescription Medication2024-07-09
Amgen Inc
Prescription Medication2024-07-01
Amgen Inc
Prescription Medication2024-06-25
Amgen Inc
Prescription Medication2024-05-30
Amgen Inc, Amgen, Inc
Prescription Medication2024-05-22
Amgen Inc, Amgen Manufacturing Ltd, Amgen, Inc, Patheon Manufacturing Services LLC
Prescription Medication2024-05-14
Amgen Inc
Prescription Medication2024-05-14
Janssen Products, LP, Amgen Manufacturing Ltd, Patheon Manufacturing Services LLC, Amgen, Inc.
Prescription Medication2024-05-11
Amgen Inc
Prescription Medication2024-05-09
Amgen, Inc, Amgen Europe BV
Prescription Medication2024-04-02
Amgen Inc
Prescription Medication2024-03-21
Amgen Inc
Prescription Medication2024-03-17
Amgen Inc, Amgen, Inc
Prescription Medication2024-03-08
Amgen Inc
Prescription Medication2024-02-20
Amgen Inc
Prescription Medication2024-02-10
Amgen USA Inc., Amgen, Inc
Prescription Medication2024-02-03
Amgen Inc
Prescription Medication2024-02-03
Amgen, Inc
Prescription Medication2024-01-30
Amgen Inc, Amgen, Inc
Prescription Medication2023-12-01
Janssen Products, LP, Amgen Manufacturing Ltd, Patheon Manufacturing Services LLC, Amgen, Inc.
Prescription Medication2023-11-02
Amgen Inc, Amgen, Inc
Prescription Medication2023-10-30
Amgen Inc, Amgen Manufacturing Ltd, Amgen Technology (ireland) Unlimited Company, Amgen, Inc, BioReliance Corporation
Prescription Medication2023-09-29
Amgen Inc
Prescription Medication2023-09-22
Amgen Inc
Prescription Medication2023-08-26
Amgen Inc
Prescription Medication2023-08-17
Amgen Inc
Prescription Medication2023-08-10
Amgen Inc
Prescription Medication2023-07-27
Amgen Inc, West Pharmaceutical Services, Inc.
Prescription Medication2023-07-11
Amgen Inc
Prescription Medication2023-06-30
Amgen Inc
Prescription Medication2023-06-29
Amgen Inc
Prescription Medication2023-06-29
Amgen Inc, Amgen Manufacturing Ltd
Prescription Medication2023-06-17
Amgen Inc
Prescription Medication2023-06-17
AMGEN INC.
 Repatha Pushtronex System, sample 2022-09-01
AMGEN INC.
 Repatha Pushtronex System 2021-12-22
AMGEN INC.
 Enbrel 25 mg/vial Replacement 2021-12-22
AMGEN INC.
 Repatha Pushtronex System, sample 2021-12-22
AMGEN INC.
 AutoTouch Connect reusable autoinjector 2021-11-16
AMGEN INC
2021-06-01 20:06:23
AMGEN INC
2020-12-22 23:10:48
Amgen Inc
Otezla2020-02-26
AMGEN INC.
 Enbrel 25 mg/vial Multiple-use Vial 2019-11-01
Amgen Inc
Kanjinti2019-10-28
AMGEN INC.
 AutoTouch reusable autoinjector 2019-10-02
AMGEN INC.
 Repatha Pushtronex System 2019-10-02
AMGEN INC.
 Onpro kit 2019-10-02
Amgen Inc
Nplate2019-08-02
Amgen Inc
Kanjinti2019-06-11
Amgen Inc
Corlanor2019-04-19
Amgen Inc
Evenity2019-04-09
Amgen Inc
AIMOVIG2019-03-15
Amgen Inc
AIMOVIG2019-03-15
Amgen Inc
MVASI2018-06-01
Amgen Inc
MVASI2018-06-01
Amgen Inc
AIMOVIG2018-05-22
Amgen Inc
AIMOVIG2018-05-22
Amgen Inc
PARSABIV2017-04-03
Amgen Inc
PARSABIV2017-04-03
Amgen Inc
PARSABIV2017-04-03
Amgen Inc
REPATHA2016-08-01
Amgen Inc
Imlygic2015-11-02
Amgen Inc
Imlygic2015-11-02
Amgen Inc
REPATHA2015-08-31
Amgen Inc
REPATHA2015-08-31
Amgen Inc
Corlanor2015-04-20
Amgen Inc
Corlanor2015-04-20
Amgen Inc
BLINCYTO2014-12-18
Amgen Inc
XGEVA2010-11-18
Amgen Inc
Prolia2010-06-05
Amgen Inc
Nplate2008-08-25
Amgen Inc
Nplate2008-08-25
Amgen Inc
Vectibix2006-10-10
Amgen Inc
Vectibix2006-10-10
Amgen Inc
ARANESP2006-09-11
Amgen Inc
ARANESP2006-09-11
Amgen Inc
ARANESP2006-09-11
Amgen Inc
ARANESP2006-09-11
Amgen Inc
ARANESP2006-09-11
Amgen Inc
ARANESP2006-09-11
Amgen Inc
ARANESP2006-08-26
Amgen Inc
ARANESP2006-08-26
Amgen Inc
ARANESP2006-08-14
Amgen Inc
ARANESP2006-08-14
Amgen Inc
ARANESP2006-08-14
Amgen Inc
ARANESP2006-08-14
Amgen Inc
ARANESP2006-08-14
Amgen Inc
ARANESP2006-08-14
Amgen Inc
ARANESP2006-06-07
Amgen Inc
Sensipar2004-04-04
Amgen Inc
Sensipar2004-04-04
Amgen Inc
Sensipar2004-04-04
Amgen Inc
Neulasta2002-04-01
Amgen Inc
Neulasta2002-04-01
Amgen Inc
NEUPOGEN2000-10-02
Amgen Inc
NEUPOGEN2000-10-02
Amgen Inc
NEUPOGEN1997-05-19
Amgen Inc
NEUPOGEN1997-04-07
Amgen Inc
EPOGEN1997-03-03
Amgen Inc
EPOGEN1994-12-05
Amgen Inc
EPOGEN1993-08-16
Amgen Inc
EPOGEN1993-08-16
Amgen Inc
EPOGEN1990-04-30
AMGEN, INC.
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,31989-10-10
Amgen Inc
EPOGEN1989-06-30
AMGEN, INC.
ERYTHROPOIETIN ENZYME IMMUNOASSAY1988-12-20
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00
AMGEN INC
0000-00-00 00:00:00

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