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FDA ANDA · ANDA211087

POTASSIUM CHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA211087
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-09
LATEST ACTION
2023-08-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

POTASSIUM CHLORIDE 20MEQPrescription
POTASSIUM CHLORIDE 29.8MG/ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQPrescription
POTASSIUM CHLORIDE 14.9MG/ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 40MEQPrescription
POTASSIUM CHLORIDE 2.98GM/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQPrescription
POTASSIUM CHLORIDE 746MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQPrescription
POTASSIUM CHLORIDE 1.49GM/100ML · INJECTABLE · INJECTION

Approval history

2023-08-07Labeling · Supplement 4 · standardAP
2021-05-07Manufacturing (CMC) · Supplement 1 · unknownAP
2020-09-09UNKNOWN · Original · standard — Letter ↗AP
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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