Fresenius Kabi Norge A S

FDA Filings

This page includes the latest FDA filings for Fresenius Kabi Norge A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3002608066
FEI Number	3002608066
Name	FRESENIUS KABI NORGE AS
Owner & Operator	Fresenius Kabi Norge AS
Contact Address	Svinesundsveien 80 Halden NO-01 Ostfold 1778 NO
US Agent	David Lennarz Registrar Corp 757 2240177 757 2240179 david.lennarz@registrarcorp.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	Svinesundsveien 80 Halden Ostfold, 1778 NO
Establishment Type	Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
LACTATED RINGERS Becton Dickinson and Company, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2024-10-20
Xenleta Nabriva Therapeutics US, Inc., Nabriva Therapeutics Ireland DAC, SEL Biochem Xinjiang Co., Ltd, Hovione Limited, Charles River Laboratories, Hovione FarmaCiencia SA Central Stability Laboratory, Patheon Italia S.p.A, Fresenius Kabi Norge AS, Almac Pharma Services	Prescription Medication	2024-10-13
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2024-09-27
Zyvox Pharmacia and Upjohn Company LLC, Fresenius Kabi Norge AS, Pfizer Pharmaceuticals LLC, Pfizer Asia Manufacturing Pte Ltd	Prescription Medication	2024-09-27
POTASSIUM CHLORIDE Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-08-29
Dextrose Becton Dickinson and Company, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH, Fresenius Kabi USA, LLC	Prescription Medication	2024-08-23
Naropin Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS	Prescription Medication	2024-08-14
sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2024-08-06
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2024-08-06
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, NEOLPHARMA, INC., Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2024-07-26
Moxifloxacin Hp Halden Pharma AS	Prescription Medication	2024-07-19
Linezolid Hp Halden Pharma AS	Prescription Medication	2024-07-19
Zyvox Pharmacia and Upjohn Company LLC, Fresenius Kabi Norge AS, Pfizer Pharmaceuticals LLC, Pfizer Asia Manufacturing Pte Ltd	Prescription Medication	2024-07-16
Potassium Chloride in Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2024-06-25
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, NEOLPHARMA, INC., Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2024-06-19
Zyvox Hp Halden Pharma AS	Prescription Medication	2024-05-30
Zyvox Hp Halden Pharma AS	Prescription Medication	2024-05-30
Zyvox Hp Halden Pharma AS	Prescription Medication	2024-05-30
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2024-05-24
Levofloxacin Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
Potassium Chloride in Lactated Ringers and Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
Sodium chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2024-05-24
Dextrose Becton Dickinson and Company, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH, Fresenius Kabi USA, LLC	Prescription Medication	2024-05-24
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
LACTATED RINGERS Becton Dickinson and Company, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2024-05-24
sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
Naropin Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
POTASSIUM CHLORIDE Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
Sodium chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2024-05-24
Lactated Ringers and Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-24
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, NEOLPHARMA, INC., Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2024-05-22
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2024-05-22
Xylocaine Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-17
Naropin Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS	Prescription Medication	2024-05-17
Magnesium Sulfate in 5% Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-15
Magnesium Sulfate in 5% Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-15
Potassium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-11
Potassium Chloride in Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-09
Moxifloxacin Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2024-05-09
Potassium Chloride in Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2024-05-09
Calcium Gluconate Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2024-05-09
Heparin Sodium Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-03
Linezolid Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-02
Heparin Sodium Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-05-02
magnesium sulfate Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2024-04-27
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, HP Halden Pharma AS	Prescription Medication	2024-04-27
Acetaminophen Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-04-27
LACTATED RINGERS Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2024-04-27
magnesium sulfate Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2024-04-27
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2024-04-26
Xylocaine Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-03-16
Linezolid Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-03-15
Naropin Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS	Prescription Medication	2024-02-29
Sodium chloride Becton Dickinson and Company, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2024-01-13
POTASSIUM CHLORIDE Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2024-01-05
Naropin Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS	Prescription Medication	2023-12-02
Xylocaine Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2023-11-21
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, NEOLPHARMA, INC., Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2023-09-01
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2023-08-31
Zyvox Pharmacia and Upjohn Company LLC, Fresenius Kabi Norge AS, Pfizer Pharmaceuticals LLC, Pfizer Asia Manufacturing Pte Ltd	Prescription Medication	2023-08-31
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, NEOLPHARMA, INC., Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2023-08-04
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2023-07-22
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, HP Halden Pharma AS	Prescription Medication	2023-07-20
Heparin Sodium Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2023-07-11
Potassium Chloride in Lactated Ringers and Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2023-06-07
Calcium Gluconate Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2023-06-01
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, NEOLPHARMA, INC., Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2023-05-17
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2023-05-17
LACTATED RINGERS Becton Dickinson and Company, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH, Fresenius Medical Care North America, Fresenius Kabi USA, LLC	Prescription Medication	2023-04-29
Heparin Sodium Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2023-04-08
Moxifloxacin Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2023-04-08
Zyvox Pharmacia & Upjohn Company LLC, Pfizer Asia Manufacturing Pte Ltd, NEOLPHARMA, INC., Pfizer Inc, Pfizer Laboratories Div Pfizer Inc	Prescription Medication	2023-04-01
POTASSIUM CHLORIDE Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2023-03-25
Lactated Ringers and Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2023-01-18
Potassium Chloride in Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2023-01-07
Xenleta Nabriva Therapeutics US, Inc., Nabriva Therapeutics Ireland DAC, SEL Biochem Xinjiang Co., Ltd, Hovione Limited, Charles River Laboratories, Hovione FarmaCiencia SA Central Stability Laboratory, Patheon Italia S.p.A, Fresenius Kabi Norge AS, Almac Pharma Services	Prescription Medication	2022-12-28
magnesium sulfate Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2022-12-13
Magnesium Sulfate in 5% Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-12-13
Levofloxacin Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-12-13
Glycophos Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-12-13
Xylocaine Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-12-13
Magnesium Sulfate in 5% Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-12-13
Heparin Sodium Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-12-13
Moxifloxacin Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2022-12-13
LACTATED RINGERS Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2022-12-13
Naropin Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-12-13
magnesium sulfate Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2022-12-13
Potassium Chloride in Lactated Ringers and Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-11-12
Potassium Chloride in Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-11-11
Potassium Chloride in Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-11-01
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, HP Halden Pharma AS	Prescription Medication	2022-10-29
Sodium chloride Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2022-10-29
POTASSIUM CHLORIDE Fresenius Kabi USA, LLC, Fresenius Kabi Norge AS	Prescription Medication	2022-10-21
Dextrose Becton Dickinson and Company, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH, Fresenius Kabi USA, LLC	Prescription Medication	2022-09-28
Potassium Chloride in Dextrose and Sodium Chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS	Prescription Medication	2022-09-22
Dextrose Fresenius Kabi USA, LLC, Fresenius Kabi Deutschland GmbH, Fresenius Kabi Norge AS	Prescription Medication	2022-03-02
Sodium chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-03-01
Sodium chloride Fresenius Kabi USA, LLC, HP Halden Pharma AS, Fresenius Kabi Deutschland GmbH	Prescription Medication	2022-03-01
Naropin Fresenius Kabi USA, LLC, Fresenius Kabi Austria, HP Halden Pharma AS	Prescription Medication	2022-02-15
NDC 66298-5197 Fresenius Kabi Norge AS	Heparin Sodium	2020-07-24
NDC 66298-5191 Fresenius Kabi Norge AS	Heparin Sodium	2020-07-24
NDC 66298-7807 Fresenius Kabi Norge As	Zyvox	2018-06-05
NDC 66298-5140 Fresenius Kabi Norge As	Zyvox	2018-06-05
NDC 66298-4992 Fresenius Kabi Norge As	Zyvox	2018-06-05
NDC 66298-5137 Fresenius Kabi Norge As	Zyvox	2018-06-04
NDC 66298-8507 Fresenius Kabi Norge AS	Moxifloxacin	2017-08-02
NDC 66298-1060 Fresenius Kabi Norge AS	Magnesium Sulfate	2017-08-02
NDC 66298-1070 Fresenius Kabi Norge AS	Magnesium Sulfate	2017-08-01
NDC 66298-7131 Fresenius Kabi Norge AS	Linezolid	2017-07-27

Related Finance Registrations

NCAGE Code	N5086	FRESENIUS KABI NORGE AS
CAGE Code	N5086	FRESENIUS KABI NORGE AS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092932385	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	0.9 SODIUM CHLORIDE INJ. 100 ML (BD) US TEMPERATURE 23 DEGR.C DELIVERY 3518489187 HS-CODE 30049008	67600 PCS
2020092932385	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	LINEZOLID 2MG ML FREE FLEXBAG TEMPERATURE 23 DEGR.C DELIVERY 3518490010 LOADED ON 40 PALLETS HS-CODE 30049008	67600 PCS
2020092932466	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	0.9 SODIUM CHLORIDE INJ. 50ML (BD) USP TEMPERATURE 23 DEGR.C DELIVERY 3518546477 HS-CODE 30049008	74220 PCS
2020092932466	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	0.9 SODIUM CHLORIDE INJ. 50ML (BD) USP TEMPERATURE 23 DEGR.C DELIVERY 3518546261 HS-CODE 30049008	74220 PCS
2020092932466	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	0.9 SODIUM CHLORIDE INJ. 250ML (BD) USP TEMPERATURE 23 DEGR.C DELIVERY 3518546158 HS-CODE 30049008	74220 PCS
2020092932466	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	0.9 SODIUM CHLORIDE INJ. 250ML (BD) USP TEMPERATURE 23 DEGR.C DELIVERY 3518546067 HS-CODE 30049008	74220 PCS
2020092932466	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	PCS 0.9 SODIUM CHLORIDE INJ. 50ML (BD) USP TEMPERATURE 23 DEGR.C DELIVERY 3518546458 LOADED ON 20 PALLETS HS-CODE 30049008	74220 PCS
2020092975281	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	LACTATED RINGERS 1000ML BD US TEMPERATURE 23 DEGR.C DELIVERY 3518640084 LOADED ON 15 PALLETS HS-CODE 30049008	13150 PCS
2020092932464	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	LINEZOLID 2MG ML FREE FLEXBAG TEMPERATURE 23 DEGR.C DELIVERY 3518490015 LOADED ON 20 PALLETS HS-CODE 30049008	18000 PCS
2020092975283	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	MAGNESIUM SULFATE IN WFI 4G, 50ML TEMPERATURE 23 DEGR.C DELIVERY 3518570234 HS-CODE 30049008	67200 PCS
2020092975283	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	MAGNESIUM SULFATE IN WFI 2G. 50ML TEMPERATURE 23 DEGR.C DELIVERY 3518570259 LOADED ON 40 PALLETS HS-CODE 30049008	67200 PCS
2020092932465	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	LINEZOLID 2MG ML FREE FLEXBAG TEMPERATURE 23 DEGR.C DELIVERY 3518534701 HS-CODE 30049008	29000 PCS
2020092932465	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	MAGNESIUM SULFATE IN WFI 2G, 50ML TEMPERATURE 23 DEGR.C DELIVERY 3518535374 LOADED ON 20 PALLETS HS-CODE 30049008	29000 PCS
2020092975282	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	380 PCS LACTATED RINGERS 1000ML US TEMPERATURE 23 DEGR.C DELIVERY 3518655802 HS-CODE 30049008	9510 PCS
2020092975282	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	LACTATED RINGERS 1000ML US TEMPERATURE 23 DEGR.C DELIVERY 3518652330 LOADED ON 21 PALLETS HS-CODE 30049008	9510 PCS
2020092870677	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	LACTATED RINGERS 1000ML BD US TEMPERATURE 23 DEGR.C DELIVERY 3518685687	13580 PCS
2020092870677	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	LACTATED RINGERS 1000ML BD US TEMPERATURE 23 DEGR.C DELIVERY 3518697353 LOADED ON 15 PALLETS HS-CODE 30049008	13580 PCS