Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211276
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/15/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

INJECTABLE;INJECTION; 5GM/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 211276 FRESENIUS KABI USA
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017607 ICU MEDICAL INC
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 016683 BAXTER HLTHCARE

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