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FDA ANDA · ANDA216274

POTASSIUM PHOSPHATES

Sponsor: AM REGENT

APPLICATION
ANDA216274
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-02
LATEST ACTION
2025-01-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

POTASSIUM PHOSPHATESPrescription
POTASSIUM PHOSPHATE, DIBASIC 3.54GM/15ML (236MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 3.36GM/15ML (224MG/ML) · SOLUTION · INTRAVENOUS
POTASSIUM PHOSPHATESPrescription
POTASSIUM PHOSPHATE, DIBASIC 11.8GM/50ML (236MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 11.2GM/50ML (224MG/ML) · SOLUTION · INTRAVENOUS
POTASSIUM PHOSPHATESPrescription
POTASSIUM PHOSPHATE, DIBASIC 1.18GM/5ML (236MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 1.12GM/5ML (224MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-01-30Manufacturing (CMC) · Supplement 2 · standardAP
2023-10-02UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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