Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212346
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;75MG/100ML INJECTABLE;INJECTION Discontinued None No No
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;150MG/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
09/10/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212346Orig1s000ltr.pdf

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