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Fresenius Kabi USA FDA Approvals
58 new drug approvals and 0 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENew drugAug 4, 2026INJECTABLE, INTRAVENOUS |
| GLYCOPHOSNew drugJul 29, 2026SOLUTION, INTRAVENOUS |
| SUGAMMADEX SODIUMNew drugJul 28, 2026SOLUTION, INTRAVENOUS |
| LIRAGLUTIDENew drugMar 30, 2026SOLUTION, SUBCUTANEOUS |
| EPHEDRINE SULFATENew drugMar 19, 2026SOLUTION, INTRAVENOUS |
| DALBAVANCIN HYDROCHLORIDENew drugNov 10, 2025POWDER, INTRAVENOUS |
| SODIUM BICARBONATENew drugAug 25, 2025SOLUTION, INTRAVENOUS |
| ASCORBIC ACIDNew drugAug 7, 2025SOLUTION, INTRAVENOUS |
| MANGANESE CHLORIDENew drugJul 7, 2025INJECTABLE, INJECTION |
| ROCURONIUM BROMIDENew drugJun 9, 2025SOLUTION, INTRAVENOUS |
| TYENNENew drugMar 14, 2025INJECTABLE, SUBCUTANEOUS |
| EPINEPHRINENew drugMar 13, 2025SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| EPHEDRINE SULFATENew drugMar 11, 2025SOLUTION, INTRAVENOUS |
| SUCCINYLCHOLINE CHLORIDENew drugFeb 21, 2025INJECTABLE, INJECTION |
| SUCCINYLCHOLINE CHLORIDENew drugFeb 11, 2025SOLUTION, INTRAMUSCULAR, INTRAVENOUS |
| SELENIOUS ACIDNew drugFeb 10, 2025SOLUTION, INTRAVENOUS |
| CALCITONIN-SALMONNew drugDec 5, 2024INJECTABLE, INJECTION |
| POTASSIUM ACETATENew drugNov 27, 2024INJECTABLE, INJECTION |
| EPINEPHRINENew drugNov 20, 2024SOLUTION, INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS |
| LORAZEPAMNew drugNov 18, 2024INJECTABLE, INJECTION |
| OTULFINew drugSep 27, 2024INJECTABLE, INJECTION |
| TRANEXAMIC ACIDNew drugAug 15, 2024SOLUTION, INTRAVENOUS |
| STERILE WATER FOR IRRIGATIONNew drugAug 12, 2024LIQUID, IRRIGATION |
| PANTOPRAZOLE SODIUMNew drugAug 1, 2024POWDER, INTRAVENOUS |
| DAPTOMYCINNew drugAug 1, 2024POWDER, INTRAVENOUS |
| ACYCLOVIR SODIUMNew drugJun 25, 2024INJECTABLE, INJECTION |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERNew drugJun 24, 2024SOLUTION, IRRIGATION |
| VERAPAMIL HYDROCHLORIDENew drugApr 23, 2024INJECTABLE, INJECTION |
| MITOMYCINNew drugApr 5, 2024INJECTABLE, INJECTION |
| NALOXONE HYDROCHLORIDENew drugApr 2, 2024INJECTABLE, INJECTION |
| TYENNENew drugMar 5, 2024INJECTABLE, INTRAVENOUS |
| POSACONAZOLENew drugDec 26, 2023SOLUTION, INTRAVENOUS |
| SODIUM CHLORIDE 23.4%New drugJul 11, 2023INJECTABLE, INJECTION |
| VASOPRESSINNew drugMay 26, 2023SOLUTION, INTRAVENOUS |
| LEVETIRACETAM IN SODIUM CHLORIDENew drugJan 31, 2023INJECTABLE, INTRAVENOUS |
| KETAMINE HYDROCHLORIDENew drugJan 13, 2023INJECTABLE, INJECTION |
| ZINC SULFATENew drugDec 27, 2022SOLUTION, INTRAVENOUS |
| IDACIONew drugDec 13, 2022INJECTABLE, SUBCUTANEOUS |
| DIAZEPAMNew drugNov 10, 2022INJECTABLE, INJECTION |
| ISOSULFAN BLUENew drugSep 8, 2022SOLUTION, SUBCUTANEOUS |
| STIMUFENDNew drugSep 1, 2022SOLUTION, INJECTION |
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5New drugJun 29, 2022INJECTABLE, INJECTION |
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4New drugJun 8, 2022INJECTABLE, INJECTION |
| PEMETREXED DISODIUMNew drugMay 25, 2022POWDER, INTRAVENOUS |
| LACOSAMIDENew drugMay 3, 2022SOLUTION, INTRAVENOUS |
| BORTEZOMIBNew drugMay 2, 2022INJECTABLE, INTRAVENOUS, SUBCUTANEOUS |
| GLYCOPYRROLATENew drugApr 21, 2022SOLUTION, INTRAMUSCULAR, INTRAVENOUS |
| SODIUM PHOSPHATESNew drugMar 30, 2022SOLUTION, INTRAVENOUS |
| DEXTROSE 5% AND LACTATED RINGER'SNew drugMar 28, 2022INJECTABLE, INJECTION |
| CARDIOPLEGIC IN PLASTIC CONTAINERNew drugFeb 18, 2022SOLUTION, PERFUSION, CARDIAC |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINERNew drugNov 9, 2021INJECTABLE, INJECTION |
| ROMIDEPSINNew drugOct 12, 2021POWDER, INTRAVENOUS |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERNew drugJul 30, 2021INJECTABLE, INJECTION |
| SODIUM CHLORIDE 23.4%New drugApr 28, 2021INJECTABLE, INJECTION |
| SODIUM CHLORIDE 23.4%New drugApr 28, 2021SOLUTION, INTRAVENOUS |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%New drugMar 9, 2021INJECTABLE, INJECTION |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%New drugMar 9, 2021INJECTABLE, INJECTION |
| FOSCARNET SODIUMNew drugJan 29, 2021SOLUTION, INTRAVENOUS |