APPLICATION
ANDA203562
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-26
LATEST ACTION
2021-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
POTASSIUM CHLORIDEPrescription
POTASSIUM CHLORIDE 10MEQ · TABLET, EXTENDED RELEASE · ORAL
POTASSIUM CHLORIDEPrescription
POTASSIUM CHLORIDE 20MEQ · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-02-26Manufacturing (CMC) · Supplement 3AP
2021-02-26Labeling · Supplement 2 · standardAP
2016-07-26UNKNOWN · OriginalAP
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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