Regulatorische Updates
19. Sept. 2026•1 Min. Lesezeit
FDA Approves Dextrose 10% & Sodium Chloride 0.9% Injectable (Now Discontinued)
The FDA record NDA018047 shows approval of an injectable solution containing 10% dextrose and 0.9% sodium chloride, now listed as discontinued.
Regulatorische Updates
12. Sept. 2026•1 Min. Lesezeit
FDA Approves Supplemental Manufacturing Submissions for Discontinued Sodium Chloride 0.45% Irrigation Solution
The FDA has approved a series of supplemental manufacturing (CMC) and labeling submissions for the discontinued irrigation product SODIUM CHLORIDE 0.45% in plastic containers.
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Regulatorische Updates
9. Sept. 2026•1 Min. Lesezeit
FDA Approves Sodium Chloride Injection (NDA018090)
The FDA has approved NDA018090 for Sodium Chloride 0.45% injectable, manufactured by ICU Medical Inc.
Regulatorische Updates
8. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA076316 for Sodium Chloride 0.9% Injection
The FDA has granted approval for ANDA076316, a prescription injectable sodium chloride 0.9% solution in a plastic container, submitted by GVS TM.