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Abbreviated New Drug Application (ANDA): 212347
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription AP No No
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/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
09/17/2020 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212347Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212347Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/17/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212347Orig1s000ltr.pdf

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%

INJECTABLE;INJECTION; 150MG/100ML;450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017648 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription No AP 212347 FRESENIUS KABI USA

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%

INJECTABLE;INJECTION; 150MG/100ML;900MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017648 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 212347 FRESENIUS KABI USA
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 019708 B BRAUN

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%

INJECTABLE;INJECTION; 300MG/100ML;900MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017648 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 212347 FRESENIUS KABI USA
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