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Abbreviated New Drug Application (ANDA): 211221
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% DEXTROSE; SODIUM CHLORIDE 5GM/100ML;225MG/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 Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211221Orig1s000ltr.pdf

DEXTROSE 5% AND SODIUM CHLORIDE 0.225%

INJECTABLE;INJECTION; 5GM/100ML;225MG/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 0.225% DEXTROSE; SODIUM CHLORIDE 5GM/100ML;225MG/100ML INJECTABLE;INJECTION Prescription No AP 211221 FRESENIUS KABI USA
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;225MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017606 ICU MEDICAL INC
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