Fresenius Kabi

FDA Filings

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

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
Glycopyrrolate Fresenius Kabi USA, LLC, Fresenius Kabi, USA LLC	Prescription Medication	2023-08-25
Ofirmev Mallinckrodt Hospital Products Inc., Catalent Anagni S.R.L., SpecGx LLC, Fresenius Kabi	Prescription Medication	2021-12-12
Glycopyrrolate Fresenius Kabi USA, LLC, Fresenius Kabi, USA LLC	Prescription Medication	2021-01-31
Glycopyrrolate Fresenius Kabi USA, LLC, Fresenius Kabi, USA LLC	Prescription Medication	2020-10-30
Ofirmev Mallinckrodt Hospital Products Inc., Catalent Anagni S.R.L., SpecGx LLC, Fresenius Kabi	Prescription Medication	2020-10-14
Ofirmev Mallinckrodt Hospital Products Inc., Catalent Anagni S.R.L., SpecGx LLC, Fresenius Kabi	Prescription Medication	2020-09-19
Ofirmev Mallinckrodt Hospital Products Inc., Catalent Anagni S.R.L., SpecGx LLC, Fresenius Kabi	Prescription Medication	2020-03-10
Glycopyrrolate Fresenius Kabi USA, LLC, Fresenius Kabi, USA LLC	Prescription Medication	2020-01-01
Ofirmev Mallinckrodt Hospital Products Inc., Catalent Anagni S.R.L., SpecGx LLC, Fresenius Kabi	Prescription Medication	2019-04-18
Glycopyrrolate Fresenius Kabi USA, LLC, Fresenius Kabi, USA LLC	Prescription Medication	2018-11-07
NDC 76045-203 Fresenius Kabi	Glycopyrrolate	2018-07-25
PMN BK170030 Fresenius Kabi	Kit, Bone Marrow Collection	2017-07-24
PMN BK160042 Fresenius Kabi	Kit, Bone Marrow Collection	2016-06-09
203720 ANDA FRESENIUS KABI		0000-00-00 00:00:00
203719 ANDA FRESENIUS KABI		0000-00-00 00:00:00

Similar & Related FDA Registered Companies

• Fresenius Kabi USA, LLC
• Fresenius Kabi LLC
• Fresenius Kabi USA
• Fresenius Kabi Deutschland GmbH
• Fresenius Kabi AB
• Fresenius Kabi AG
• Fresenius Kabi Norge AS
• Fresenius Kabi AB Uppsala
• Fresenius Kabi Austria
• Fresenius Kabi Austria GmbH
• Fresenius Kabi Austria Graz
• Fresenius Kabi AUT GmbH
• Fresenius Kabi Horatev CZ s.r.o.
• FRESENIUS KABI iPSUM S.r.l
• Mallinckrodt Hospital Products Inc.
• Catalent Anagni S.R.L.
• SpecGx LLC

Related Finance Registrations

NCAGE Code	3N80F	FRESENIUS KABI
NCAGE Code	B4652	FRESENIUS KABI
CAGE Code	3N80F	FRESENIUS KABI
CAGE Code	B4652	FRESENIUS KABI

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009261374	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	PHARMACEUTICALS SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15TO PLUS 25 DEGREES CELSIUS HS-CODE 30045000	44 PKG
2020092678027	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	PHARMACEUTICALS SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG
2020092668890	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	PHARMACEUTICALS SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15TO PLUS 25 DEGREES CELSIUS HS-CODE 30045000	46 PKG
202009261373	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	PHARMA DIPRIVAN SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15 TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG
2020092562578	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	PHARMACEUTICALS SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG
2020092517357	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	PHARMA INTRALIPID SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15 TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG
2020092517355	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	PHARMA INTRALIPID SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15 TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG
2020092459937	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	PHARMACEUTICALS SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG