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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213445
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;900MG/100ML INJECTABLE;INJECTION Discontinued None No No
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;900MG/100ML INJECTABLE;INJECTION Discontinued None 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
03/09/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213445Orig1s000ltr.pdf
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