APPLICATION
ANDA085870
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-21
LATEST ACTION
2022-12-06
ROUTE
PARENTERAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
POTASSIUM CHLORIDEPrescription
POTASSIUM CHLORIDE 2MEQ/ML · INJECTABLE · INJECTION
Approval history
2022-12-06Labeling · Supplement 38 · standardAP
2022-12-02Labeling · Supplement 39 · standardAP
2004-03-19Labeling · Supplement 20AP
2002-10-07Manufacturing (CMC) · Supplement 18AP
1998-07-24Manufacturing (CMC) · Supplement 16AP
1992-02-05Labeling · Supplement 15AP
1990-02-22Labeling · Supplement 14AP
1983-07-22Manufacturing (CMC) · Supplement 10AP
1983-07-22Manufacturing (CMC) · Supplement 8AP
1982-09-23Manufacturing (CMC) · Supplement 5AP
1982-09-23Manufacturing (CMC) · Supplement 3AP
1982-09-23Manufacturing (CMC) · Supplement 6AP
1982-09-23Manufacturing (CMC) · Supplement 4AP
1978-03-21OriginalAP
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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