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Abbreviated New Drug Application (ANDA): 209997
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription AP No Yes
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription AP No 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
03/30/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209997Orig1s000ltr.pdf

SODIUM PHOSPHATES

SOLUTION;INTRAVENOUS; 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218314 AM REGENT
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209997 FRESENIUS KABI USA

SOLUTION;INTRAVENOUS; 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218314 AM REGENT
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209997 FRESENIUS KABI USA
SODIUM PHOSPHATES IN PLASTIC CONTAINER SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 018892 HOSPIRA

SOLUTION;INTRAVENOUS; 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218314 AM REGENT
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209997 FRESENIUS KABI USA
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