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 Number3003708554
FEI Number3003708554
NameFRESENIUS KABI AUSTRIA GMBH
Owner & OperatorFRESENIUS KABI DEUTSCHLAND GMBH
Contact AddressELSE-KRONER STRASSE 1 --
BAD HOMBURG V.D.H. DE-NOTA D-61325 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressHAFNERSTRASSE 36
GRAZ Steiermark, A-8055 AT
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)



FDA Filings

Device
Company
DeviceDate
Fresenius Kabi USA, LLC, Fresenius Kabi Austria
Prescription Medication2024-03-08
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 Medication2023-10-26
Hospira, Inc.
Prescription Medication2023-08-29
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH
Prescription Medication2023-07-07
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, Merck Serono S.p.A (MS-Bari)
Prescription Medication2023-07-07
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, Merck Serono S.p.A (MS-Bari)
Prescription Medication2023-07-01
Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH
Prescription Medication2023-02-16
Fresenius Kabi Austria GmbH
Prescription Medication2022-11-18
Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH
Prescription Medication2022-11-12
Actavis Pharma, Inc., Fresenius Kabi Austria GmbH
Prescription Medication2022-10-13
Actavis Pharma, Inc., Fresenius Kabi Austria GmbH
Prescription Medication2022-10-13
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 Medication2022-10-07
Hospira, Inc.
Prescription Medication2022-08-17
Fresenius Kabi USA, LLC, Fresenius Kabi Austria
Prescription Medication2021-11-16
Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH
Prescription Medication2021-10-19
Fresenius Kabi USA, LLC, Fresenius Kabi Austria
Prescription Medication2021-04-28
Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH
Prescription Medication2021-04-03
Hospira, Inc.
Prescription Medication2021-02-03
Fresenius Kabi USA, LLC, Fresenius Kabi Austria
Prescription Medication2020-12-10
Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH
Prescription Medication2020-06-30
Fresenius Kabi Austria GmbH, Fresenius Kabi Austria
Prescription Medication2020-06-17
Hospira, Inc.
Prescription Medication2020-06-11
Fresenius Kabi Austria GmbH
Fresenius Propoven 2%2020-06-05
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH
Prescription Medication2020-01-27
Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH
Prescription Medication2020-01-01
Fresenius Kabi Austria GmbH
Prescription Medication2020-01-01
Hospira, Inc.
Prescription Medication2019-12-17
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]
OCS Lung Solution2019-11-11
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]
OCS Lung Solution2019-11-11
Fresenius Kabi USA, LLC, Fresenius Kabi Austria
Prescription Medication2019-07-16
Fresenius Kabi USA, LLC, Fresenius Kabi Austria
Prescription Medication2019-06-01
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH
Prescription Medication2019-05-14
Fresenius Kabi Austria GmbH
Prescription Medication2018-12-28
Actavis Pharma, Inc., Fresenius Kabi Austria GmbH
Prescription Medication2018-12-14
Actavis Pharma, Inc., Fresenius Kabi Austria GmbH
Prescription Medication2018-12-14
Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH
Prescription Medication2018-11-14
Hospira, Inc.
Prescription Medication2018-11-07
Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH
Prescription Medication2018-05-21
Fresenius Kabi Austria GmbH, Fresenius Kabi Austria
Prescription Medication2017-05-04
Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH
Prescription Medication2017-04-14
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]
Rotaglide Lubricant2014-05-19
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH]
Rotaglide Lubricant2014-05-19
Fresenius Kabi Austria GmbH
Lactulose2012-12-10
Fresenius Kabi Austria GmbH
Lactulose2012-12-10
Fresenius Kabi Austria GmbH
2011-02-03
Fresenius Kabi Austria GmbH
Cleviprex2008-09-15

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091965592Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaHS CODE 30049000 PHARMACEUTICALS40 PKG
2020091965592Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaHS CODE 30049000 PHARMACEUTICALS40 PKG
2020091793204Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaHS CODE 30049000 PHARMACEUTICALS40 PKG
2020091793204Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaHS CODE 30049000 PHARMACEUTICALS40 PKG
2020091756580Stadersand,Federal Republic of Germany -> Houston, TexasHYDROXYETHYL STARCH (HETASTARCH) BATCH NO. 17192641, 17202531, 1720254111 PCS
2020091668590Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaHS CODE 30049000 PHARMACEUTICALS40 PKG
2020091668590Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaHS CODE 30049000 PHARMACEUTICALS40 PKG
2020091667211Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPCE CONSTULOSE 9.600 PCE CONSTULOSE 32OZ (946ML) USA BATCH NO. 17202971 BOTTLES PER SHIPPER CARTON 6 PCE SHIPPERS CARTONS PER CONTAINER 1.600 PCE1600 PCS
2020091667200Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPCE CONSTULOSE 9.600 PCE CONSTULOSE 32OZ (946ML) USA BATCH NO. 17202971 BOTTLES PER SHIPPER CARTON 6 PCE SHIPPERS CARTONS PER CONTAINER 1.600 PCE1600 PCS
2020091667209Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPCE CONSTULOSE 9.600 PCE CONSTULOSE 32OZ (946ML) USA BATCH NO. 17202971 BOTTLES PER SHIPPER CARTON 6 PCE SHIPPERS CARTONS PER CONTAINER 1.600 PCE1600 PCS
2020091073099Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaHS CODE HS CODE 30049000 PHARMACEUTICALS20 PKG

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