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.
| 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 |
|
| 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) |
Device Company | Device | Date |
|---|---|---|
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH | Prescription Medication | 2024-04-15 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria | Prescription Medication | 2024-03-08 |
| 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 Medication | 2023-10-26 |
| Hospira, Inc. | Prescription Medication | 2023-08-29 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH | Prescription Medication | 2023-07-07 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, Merck Serono S.p.A (MS-Bari) | Prescription Medication | 2023-07-07 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH, Merck Serono S.p.A (MS-Bari) | Prescription Medication | 2023-07-01 |
| Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2023-02-16 |
| Fresenius Kabi Austria GmbH | Prescription Medication | 2022-11-18 |
| Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH | Prescription Medication | 2022-11-12 |
| Actavis Pharma, Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2022-10-13 |
| Actavis Pharma, Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2022-10-13 |
| 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 Medication | 2022-10-07 |
| Hospira, Inc. | Prescription Medication | 2022-08-17 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria | Prescription Medication | 2021-11-16 |
| Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2021-10-19 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria | Prescription Medication | 2021-04-28 |
| Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2021-04-03 |
| Hospira, Inc. | Prescription Medication | 2021-02-03 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria | Prescription Medication | 2020-12-10 |
| Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2020-06-30 |
| Fresenius Kabi Austria GmbH, Fresenius Kabi Austria | Prescription Medication | 2020-06-17 |
| Hospira, Inc. | Prescription Medication | 2020-06-11 |
| Fresenius Kabi Austria GmbH | Fresenius Propoven 2% | 2020-06-05 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH | Prescription Medication | 2020-01-27 |
| Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH | Prescription Medication | 2020-01-01 |
| Fresenius Kabi Austria GmbH | Prescription Medication | 2020-01-01 |
| Hospira, Inc. | Prescription Medication | 2019-12-17 |
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH] | OCS Lung Solution | 2019-11-11 |
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH] | OCS Lung Solution | 2019-11-11 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria | Prescription Medication | 2019-07-16 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria | Prescription Medication | 2019-06-01 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH | Prescription Medication | 2019-05-14 |
| Fresenius Kabi Austria GmbH | Prescription Medication | 2018-12-28 |
| Actavis Pharma, Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2018-12-14 |
| Actavis Pharma, Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2018-12-14 |
| Fresenius Kabi USA, LLC, Fresenius Kabi Austria GmbH | Prescription Medication | 2018-11-14 |
| Hospira, Inc. | Prescription Medication | 2018-11-07 |
| Hospira, Inc., BioTime Inc., Fresenius Kabi Austria GmbH | Prescription Medication | 2018-05-21 |
| Fresenius Kabi Austria GmbH, Fresenius Kabi Austria | Prescription Medication | 2017-05-04 |
| Fresenius Kabi Austria GmbH, Fresenius Kabi AUT GmbH | Prescription Medication | 2017-04-14 |
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH] | Rotaglide Lubricant | 2014-05-19 |
FRESENIUS KABI AUSTRIA GMBH [FRESENIUS KABI DEUTSCHLAND GMBH] | Rotaglide Lubricant | 2014-05-19 |
| Fresenius Kabi Austria GmbH | Lactulose | 2012-12-10 |
| Fresenius Kabi Austria GmbH | Lactulose | 2012-12-10 |
| Fresenius Kabi Austria GmbH | 2011-02-03 | |
| Fresenius Kabi Austria GmbH | Cleviprex | 2008-09-15 |
| NCAGE Code | 2788N | FRESENIUS KABI AUSTRIA GMBH |
| CAGE Code | 2788N | FRESENIUS KABI AUSTRIA GMBH |