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New Drug Application (NDA): 212832
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/26/2019 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212832s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212832Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212832Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/26/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212832s000lbl.pdf

POTASSIUM PHOSPHATES

SOLUTION;INTRAVENOUS; 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216274 AM REGENT
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216344 AMNEAL
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 212832 FRESENIUS KABI USA

SOLUTION;INTRAVENOUS; 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216274 AM REGENT
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216344 AMNEAL
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 212832 FRESENIUS KABI USA

SOLUTION;INTRAVENOUS; 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216274 AM REGENT
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216344 AMNEAL
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 212832 FRESENIUS KABI USA
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