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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220683
Company: CAPLIN

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 No
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 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
02/23/2026 ORIG-1 Approval STANDARD

Label is not available on this site.

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 220683 CAPLIN

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 220683 CAPLIN

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 220683 CAPLIN
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