Bayer Pharma Ag

FDA Filings

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

FDA Registration(s)

• Registration Number: 3002808086
• FEI Number: 3002808086
• Name: BAYER PHARMA, AG
• Owner & Operator: Bayer Pharma, AG
• Contact Address: 800 Dwight Way ; Berkeley CA 94710 US
• US Agent:
  • Robert Kelly
  • Bayer Healthcare Pharmaceutical Inc
  • 862 4043481
  • robert.kelly@bayer.com
• Importing Logistics Registration:
  • Importer: Bayer HealthCare LLC
  • Address: 6345 Brackbill Blvd ; Mechanicsburg, PA 17050 UNITED STATES
  • Importer Type: logistics
• Importing Logistics Registration:
  • Importer: Exel Inc.
  • Address: 6345 Brackbill Blvd. ; Mechanicsburg, PA 17050 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Mullerstrasse 178 ; Berlin Berlin, D-13353 DE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 2243252
• FEI Number: 2243252
• Name: Bayer HealthCare, LLC
• Owner & Operator: Bayer Pharma, AG
• Contact Address: 800 Dwight Way ; Berkeley CA 94710 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 36 Columbia Rd ; Morristown, NJ 07960 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2025-03-28
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2025-03-28
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2024-08-06
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2024-08-06
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2024-02-24
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2024-02-14
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2024-02-14
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2023-12-08
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2023-11-11
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2023-11-11
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2023-09-21
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2023-04-06
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2022-12-08
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2022-11-10
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2022-11-09
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2022-11-09
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2022-10-07
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2022-05-13
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2022-05-06
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2022-03-10
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2022-01-07
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2021-12-21
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2021-12-12
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2021-12-03
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2021-09-10
Levitra GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2021-08-25
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2021-06-02
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2021-04-29
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2021-04-21
Levitra GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2021-04-14
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2020-12-24
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2020-11-20
Levitra GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2020-10-21
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2020-10-17
Staxyn GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2020-10-08
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2020-08-15
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2020-06-23
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2020-06-09
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2020-02-25
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2020-02-17
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2019-12-19
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2019-12-07
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2019-11-09
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2019-11-07
Magnevist Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, Bayer AG	Prescription Medication	2019-07-24
Levitra GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2019-07-24
Staxyn GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2019-07-24
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2019-07-17
Gadavist Bayer HealthCare Pharmaceuticals Inc., Bayer AG, Dynamit Nobel GmbH ES, Sharp Corporation, Quality Packaging Services International LLC, Currenta GmbH & Co. OHG	Prescription Medication	2019-07-13
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2019-07-11
Magnevist Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, Bayer AG	Prescription Medication	2019-07-10
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2019-07-09
Levitra GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2019-07-09
Avelox Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG	Prescription Medication	2019-07-09
Staxyn GlaxoSmithKline LLC, Bayer HealthCare Pharmaceuticals Inc., Bayer AG	Prescription Medication	2019-07-09
Magnevist Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, Bayer AG	Prescription Medication	2019-07-08
Avelox Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG	Prescription Medication	2019-07-05
ALIQOPA Bayer HealthCare Pharmaceuticals Inc., Sharp Corporation, Bayer AG	Prescription Medication	2019-06-07
Avelox Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG	Prescription Medication	2019-05-08
EOVIST Bayer HealthCare Pharmaceuticals Inc., Bayer AG, QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC	Prescription Medication	2019-05-02
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Sandoz Inc, Bayer Weimar GmbH und Co. KG, Bayer Pharma AG	Prescription Medication	2019-02-26
Moxifloxacin Hydrochloride Alvogen, Inc., Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG	Prescription Medication	2019-01-03
NDC 12527-8488 Bayer Pharma AG		2018-09-01
NDC 12527-0254 Bayer Pharma AG		2018-09-01
NDC 12527-0253 Bayer Pharma AG		2018-09-01
NDC 12527-0252 Bayer Pharma AG		2018-09-01
NDC 12527-0251 Bayer Pharma AG		2018-09-01
NDC 12527-0250 Bayer Pharma AG		2018-09-01
NDC 12527-0171 Bayer Pharma AG		2018-09-01
PMA P020014S051 BAYER PHARMA AG	Essure System for Permanent Birth Control	2018-04-09
PMA P020014S050 BAYER PHARMA AG	Essure System for Permanent Birth Control	2018-03-22
PMA P020014S049 BAYER PHARMA AG	Essure System for Permanent Birth Control	2017-12-04
PMA P020014S048 BAYER PHARMA AG	ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2016-12-14
PMA P020014S046 BAYER PHARMA AG	ESSURE SYSTEM	2016-11-15
NDC 12527-0787 Bayer Pharma AG		2016-10-07
PMA P020014S047 BAYER PHARMA AG	Essure System for Permanent Birth Control (Model ESS305)	2016-09-29
NDC 12527-0540 Bayer Pharma AG		2016-09-01
KZH BAYER PHARMA, AG	BetaConnect	2016-08-11
NDC 12527-0537 Bayer Pharma AG		2016-05-13
NDC 12527-0517 Bayer Pharma AG		2016-05-13
PMA P020014S044 BAYER PHARMA AG	ESSURE SYSTEM	2016-05-12
PMA P020014S045 BAYER PHARMA AG	ESSURE SYSTEM	2016-04-28
PMA P020014S041 BAYER PHARMA AG	ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2015-06-29
PMA P020014S043 BAYER PHARMA AG	ESSURE SYSTEM	2015-06-09
SULAR Shionogi Inc., Aenova France SAS, Bayer Pharma AG, Catalent Germany Schorndorf GmbH	Prescription Medication	2015-03-19
PMA P020014S042 BAYER PHARMA AG	ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2014-12-11
Delyla OHM LABORATORIES INC., Haupt Pharma Muenster GmbH, Bayer Pharma AG	Prescription Medication	2014-05-26
NDC 12527-0580 Bayer Pharma AG		2014-05-01
PMN P020014 | HHS Bayer HealthCare, LLC [Bayer Pharma, AG]	Essure	2014-01-10
PMN P020014 | HHS BAYER PHARMA, AG	Essure	2014-01-10
PMA P020014S040 BAYER PHARMA AG	ESSURE	2013-10-30
NDC 12527-1721 Bayer Pharma AG		2013-04-15
PMA P020014S039 BAYER PHARMA AG	ESSURE SYSTEM	2012-12-20
PMA P020014S038 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM	2012-10-02
PMA P020014S037 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM	2012-05-17
PMA P020014S036 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2012-04-19
PMA P020014S035 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2012-03-19
PMA P020014S017 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2012-02-24
PMA P020014S033 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM	2012-02-22
PMA P020014S034 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2011-07-01
PMA P020014S032 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2011-02-24
PMA P020014S029 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2010-04-06
PMA P020014S030 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2010-02-15
PMA P020014S024 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM	2009-08-26
PMA P020014S026 BAYER PHARMA AG	ESSURE SYSTEM	2009-07-16
PMA P020014S027 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2009-06-19
PMA P020014S025 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2009-06-11
PMA P020014S022 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2009-04-20
PMA P020014S018 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2009-03-16
PMA P020014S023 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2009-03-09
PMA P020014S021 BAYER PHARMA AG	ESSURE SYSTEM	2008-11-07
PMA P020014S019 BAYER PHARMA AG	ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM	2008-10-08
PMA P020014S020 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM	2008-09-11
PMA P020014S015 BAYER PHARMA AG	ESSURE SYSTEM	2008-06-10
PMA P020014S014 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2007-08-07
PMA P020014S012 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2007-06-15
PMA P020014S010 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2006-10-11
PMA P020014S013 BAYER PHARMA AG	ESSURE PERMANENT BIRTH CONTROL SYSTEM	2006-09-19
PMA P020014S009 BAYER PHARMA AG	ESSURE SYSTEM	2005-07-12
PMA P020014S008 BAYER PHARMA AG	ESSURE SYSTEM	2005-01-31
PMA P020014S006 BAYER PHARMA AG	ESSURE SYSTEM	2004-07-22
PMA P020014S005 BAYER PHARMA AG	ESSURE SYSTEM	2004-06-10
PMA P020014S007 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2004-04-08
PMA P020014S004 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2003-07-17
PMA P020014S002 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2003-07-01
PMA P020014S003 BAYER PHARMA AG	CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	2003-04-11
PMA P020014S001 BAYER PHARMA AG	ESSURE SYSTEM	2003-03-06
PMA P020014 BAYER PHARMA AG	ESSURE SYSTEM	2002-11-04
NDC 12527-8861 Bayer Pharma AG		1993-04-21
NDC 12527-8851 Bayer Pharma AG		1993-04-21
NDC 12527-8841 Bayer Pharma AG		1993-04-21

Similar & Related FDA Registered Companies

• Bayer Schering Pharma AG
• Bayer HealthCare Pharmaceuticals Inc.
• Bayer AG
• QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC
• Dynamit Nobel GmbH ES
• Sharp Corporation
• Quality Packaging Services International LLC
• Currenta GmbH & Co. OHG
• Sandoz Inc
• Bayer Weimar GmbH und Co. KG
• GlaxoSmithKline LLC
• Alvogen, Inc.
• Shionogi Inc.
• Aenova France SAS
• Catalent Germany Schorndorf GmbH
• OHM LABORATORIES INC.
• Haupt Pharma Muenster GmbH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929101534	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	CANESTEN CREMA 1% 30G MX HS CODE:30049000000	14 PCS
20200929101500	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASPIRINA ADVANCED 500MG 20S MX HS CODE:30049000000	46 PCS
20200929101535	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ULTRAVIST 370 BT 1X200ML MX HS CODE:30063000000 ULTRAVIST 370 BT 1X50ML MX HS CODE:30063000000 ULTRAVIST 370 BT 1X100ML MX HS CODE:30063000000	23 PCS
20200929101499	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	REDOXON FORTE 2G 10 TAB EFERVESCENTES MX HS CODE:3004500000	39 PCS
20200929101533	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ASPIRINA ADVANCED 500MG 20S MX HS CODE:30049000000	45 PCS
2020092859411	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	REDOXON 1G 10 TAB SAB NRJA HS CODE:2106909855	40 PCS
2020092859410	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	REDOXON 1G 10 TAB SAB NRJA HS CODE:2106909855 ASPIRINA ADVANCED 500MG 20S MX HS CODE:30049000000 REDOXON 1G 10 TAB SAB NRJA HS CODE:2106909855	39 PCS
2020092859420	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	DROSPIRENONA/EE 30 TAFI 1X21 MX HS CODE:3006600000	24 PCS