Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213523
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/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
03/09/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213523Orig1s000ltr.pdf

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

INJECTABLE;INJECTION; 5GM/100ML;74.5MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 213523 FRESENIUS KABI USA
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;74.5MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

INJECTABLE;INJECTION; 5GM/100ML;149MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 213523 FRESENIUS KABI USA
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;149MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 213523 FRESENIUS KABI USA
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 018008 BAXTER HLTHCARE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

INJECTABLE;INJECTION; 5GM/100ML;298MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 213523 FRESENIUS KABI USA
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;298MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018362 ICU MEDICAL INC

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