Fresenius Kabi Austria G M B H

FDA Filings

This page includes the latest FDA filings for Fresenius Kabi Austria G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3003708554
FEI Number	3003708554
Name	FRESENIUS KABI AUSTRIA GMBH
Owner & Operator	FRESENIUS KABI DEUTSCHLAND GMBH
Contact Address	ELSE-KRONER STRASSE 1 -- BAD HOMBURG V.D.H. DE-NOTA D-61325 DE
US Agent	Andrea Redd Senior Director, Regulatory Affairs 847 5505767 847 5507121 andrea.redd@fresenius-kabi.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	HAFNERSTRASSE 36 GRAZ Steiermark, A-8055 AT
Establishment Type	Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
STIMUFEND NORTHSTAR RX LLC, Merck Biodevelopment, Martillac, FUJIFILM Diosynth Biotechnologies UK Ltd., Merck Serono S.p.A (MS-Bari), Merck Serono S.p.A (MS-Guidonia), Istituto di Ricerche Biomediche Antoine marxer RBM S.P.A, Fresenius Kabi USA, LLC, Fresenius Kabi Austria	Prescription Medication	2025-12-29
TYENNE Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, MERCK SERONO S.p.A	Prescription Medication	2025-12-04
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2025-10-07
TYENNE Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, MERCK SERONO S.p.A	Prescription Medication	2025-10-03
Idacio Fresenius Kabi USA, LLC, Fresenius Kabi Austria, Merck Serono SPA	Prescription Medication	2025-09-18
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2025-09-14
TYENNE Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, MERCK SERONO S.p.A	Prescription Medication	2025-09-01
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2025-06-30
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2025-06-30
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2025-02-21
TYENNE Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH	Prescription Medication	2025-02-10
TYENNE Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, MERCK SERONO S.p.A	Prescription Medication	2025-02-10
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2025-01-10
Idacio Fresenius Kabi USA, LLC, Fresenius Kabi Austria, Merck Serono SPA	Prescription Medication	2025-01-10
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2024-12-22
Leucovorin calcium Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH	Prescription Medication	2024-10-31
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2024-07-11
TYENNE Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, MERCK SERONO S.p.A	Prescription Medication	2024-07-01
TYENNE Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH	Prescription Medication	2024-04-15
Fulvestrant Fresenius Kabi USA, LLC, Fresenius Kabi Austria	Prescription Medication	2024-03-08
STIMUFEND Fresenius Kabi USA, LLC, Merck Biodevelopment, Martillac, FUJIFILM Diosynth Biotechnologies UK Ltd., Merck Serono S.p.A (MS-Bari), Merck Serono S.p.A (MS-Guidonia), Istituto di Ricerche Biomediche Antoine marxer RBM S.P.A, Fresenius Kabi Austria GmbH	Prescription Medication	2023-10-26
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2023-08-29
Amikacin Sulfate Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH	Prescription Medication	2023-07-07
Idacio Fresenius Kabi USA, LLC, Fresenius Kabi Austria, Merck Serono SPA	Prescription Medication	2023-07-07
Idacio Fresenius Kabi USA, LLC, Fresenius Kabi Austria, Merck Serono SPA	Prescription Medication	2023-07-01
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2023-02-16
Cleviprex Fresenius Kabi Austria GmbH	Prescription Medication	2022-11-18
Lactulose Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH	Prescription Medication	2022-11-12
Constulose Actavis Pharma, Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2022-10-13
Enulose Actavis Pharma, Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2022-10-13
STIMUFEND Fresenius Kabi USA, LLC, Merck Biodevelopment, Martillac, FUJIFILM Diosynth Biotechnologies UK Ltd., Merck Serono S.p.A (MS-Bari), Merck Serono S.p.A (MS-Guidonia), Istituto di Ricerche Biomediche Antoine marxer RBM S.P.A, Fresenius Kabi Austria GmbH	Prescription Medication	2022-10-07
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2022-08-17
Fulvestrant Fresenius Kabi USA, LLC, Fresenius Kabi Austria	Prescription Medication	2021-11-16
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2021-10-19
Fulvestrant Fresenius Kabi USA, LLC, Fresenius Kabi Austria	Prescription Medication	2021-04-28
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2021-04-03
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2021-02-03
Fulvestrant Fresenius Kabi USA, LLC, Fresenius Kabi Austria	Prescription Medication	2020-12-10
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2020-06-30
Fresenius Propoven 2% Fresenius Kabi Austria GmbH, Fresenius Kabi Austria	Prescription Medication	2020-06-17
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2020-06-11
NDC 18124-027 Fresenius Kabi Austria GmbH	Fresenius Propoven 2%	2020-06-05
Leucovorin calcium Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH	Prescription Medication	2020-01-27
Lactulose Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH	Prescription Medication	2020-01-01
Cleviprex Fresenius Kabi Austria GmbH	Prescription Medication	2020-01-01
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2019-12-17
PMN P160013 \| QBA FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	OCS Lung Solution	2019-11-11
PMN P160013 \| PHO FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	OCS Lung Solution	2019-11-11
Fulvestrant Fresenius Kabi USA, LLC, Fresenius Kabi Austria	Prescription Medication	2019-07-16
Fulvestrant Fresenius Kabi USA, LLC, Fresenius Kabi Austria	Prescription Medication	2019-06-01
Amikacin Sulfate Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH	Prescription Medication	2019-05-14
Cleviprex Fresenius Kabi Austria GmbH	Prescription Medication	2018-12-28
Constulose Actavis Pharma, Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2018-12-14
Enulose Actavis Pharma, Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2018-12-14
Leucovorin calcium Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH	Prescription Medication	2018-11-14
Hetastarch in Sodium Chloride Hospira, Inc.	Prescription Medication	2018-11-07
Hextend Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH	Prescription Medication	2018-05-21
Lactulose Fresenius Kabi Austria GmbH, Fresenius Kabi Austria	Prescription Medication	2017-05-04
Lactulose Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH	Prescription Medication	2017-04-14
PMN P900056 \| MCX FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	Rotaglide Lubricant	2014-05-19
PMN K121774 \| MCW FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]	Rotaglide Lubricant	2014-05-19
NDC 18124-002 Fresenius Kabi Austria GmbH	Lactulose	2012-12-10
NDC 18124-001 Fresenius Kabi Austria GmbH	Lactulose	2012-12-10
NDC 18124-016 Fresenius Kabi Austria GmbH		2011-02-03
NDC 18124-011 Fresenius Kabi Austria GmbH	Cleviprex	2008-09-15

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Related Finance Registrations

NCAGE Code	2788N	FRESENIUS KABI AUSTRIA GMBH
CAGE Code	2788N	FRESENIUS KABI AUSTRIA GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091965592	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	HS CODE 30049000 PHARMACEUTICALS	40 PKG
2020091965592	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	HS CODE 30049000 PHARMACEUTICALS	40 PKG
2020091793204	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	HS CODE 30049000 PHARMACEUTICALS	40 PKG
2020091793204	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	HS CODE 30049000 PHARMACEUTICALS	40 PKG
2020091756580	Stadersand,Federal Republic of Germany -> Houston, Texas	HYDROXYETHYL STARCH (HETASTARCH) BATCH NO. 17192641, 17202531, 17202541	11 PCS
2020091668590	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	HS CODE 30049000 PHARMACEUTICALS	40 PKG
2020091668590	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	HS CODE 30049000 PHARMACEUTICALS	40 PKG
2020091667211	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PCE CONSTULOSE 9.600 PCE CONSTULOSE 32OZ (946ML) USA BATCH NO. 17202971 BOTTLES PER SHIPPER CARTON 6 PCE SHIPPERS CARTONS PER CONTAINER 1.600 PCE	1600 PCS
2020091667200	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PCE CONSTULOSE 9.600 PCE CONSTULOSE 32OZ (946ML) USA BATCH NO. 17202971 BOTTLES PER SHIPPER CARTON 6 PCE SHIPPERS CARTONS PER CONTAINER 1.600 PCE	1600 PCS
2020091667209	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PCE CONSTULOSE 9.600 PCE CONSTULOSE 32OZ (946ML) USA BATCH NO. 17202971 BOTTLES PER SHIPPER CARTON 6 PCE SHIPPERS CARTONS PER CONTAINER 1.600 PCE	1600 PCS
2020091073099	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	HS CODE HS CODE 30049000 PHARMACEUTICALS	20 PKG