APPLICATION
NDA019904
TYPE
NDA
ORIGINAL APPROVAL
1989-12-26
LATEST ACTION
2024-06-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER · ReferencePrescription
POTASSIUM CHLORIDE 1.49GM/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER · ReferencePrescription
POTASSIUM CHLORIDE 2.98GM/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER · ReferencePrescription
POTASSIUM CHLORIDE 29.8MG/ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER · ReferencePrescription
POTASSIUM CHLORIDE 746MG/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER · ReferenceDiscontinued
POTASSIUM CHLORIDE 2.24GM/100ML · INJECTABLE · INJECTION
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER · ReferencePrescription
POTASSIUM CHLORIDE 14.9MG/ML · INJECTABLE · INJECTION
Approval history
2015-02-03Manufacturing (CMC) · Supplement 15 · standardAP
2001-01-12Labeling · Supplement 5AP
1997-12-31Manufacturing (CMC) · Supplement 10 · standardAP
1996-11-06Manufacturing (CMC) · Supplement 9 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 6 · standardAP
1994-06-01Labeling · Supplement 8 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 7 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 4 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 1 · standardAP
1990-12-17Manufacturing (CMC) · Supplement 2 · standardAP
1990-12-17Labeling · Supplement 3AP
1989-12-26Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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