Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA 076235 for Carboplatin Injection (Fresenius Kabi USA)
The FDA approved ANDA 076235 for carboplatin injectable products submitted by Fresenius Kabi USA on Oct 14, 2004. All listed strengths are currently discontinued.
Regulatorische Updates
10. Sept. 2026•1 Min. Lesezeit
FDA Approves LEUCOVORIN CALCIUM (ANDA207241)
The FDA has granted approval for LEUCOVORIN CALCIUM (application ANDA207241) manufactured by Fresenius Kabi USA for prescription use.
Regulatorische Updates
8. Sept. 2026•1 Min. Lesezeit
FDA Approves FLUMAZENIL (ANDA076955) for Intravenous Use
The FDA has approved the injectable drug FLUMAZENIL (application ANDA076955) from Fresenius Kabi USA, available in two IV strengths.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA078052 for Fosphenytoin Injection
FDA has approved application ANDA078052 for fosphenytoin sodium injection, a prescription product by Fresenius Kabi USA for IM and IV use.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
FDA Approves Fresenius Kabi’s OCTREOTIDE Acetate Injectable (ANDA 077457)
The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.
Regulatorische Updates
31. Aug. 2026•1 Min. Lesezeit
FDA Approves ANDA 076484 for Ciprofloxacin Injectable Products by Fresenius Kabi USA
The FDA issued an approval letter for ANDA 076484 submitted by Fresenius Kabi USA, covering two ciprofloxacin injectable products (200 mg/20 mL and 400 mg/40 mL). Both products are listed as discontinued.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Approves ANDA077997 for Caffeine Citrate Intravenous Solution
The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.
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