APPLICATION
NDA019123
TYPE
NDA
ORIGINAL APPROVAL
1986-04-17
LATEST ACTION
2018-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
KLOR-CON · ReferencePrescription
POTASSIUM CHLORIDE 10MEQ · TABLET, EXTENDED RELEASE · ORAL
KLOR-CON · ReferencePrescription
POTASSIUM CHLORIDE 8MEQ · TABLET, EXTENDED RELEASE · ORAL
Approval history
2013-11-29Manufacturing (CMC) · Supplement 34 · standardAP
1996-07-18Manufacturing (CMC) · Supplement 19 · standardAP
1995-07-18Manufacturing (CMC) · Supplement 18 · standardAP
1994-12-16Manufacturing (CMC) · Supplement 16 · standardAP
1994-04-08Manufacturing (CMC) · Supplement 17 · standardAP
1993-07-02Manufacturing (CMC) · Supplement 15 · standardAP
1992-06-26Efficacy · Supplement 8AP
1991-10-31Manufacturing (CMC) · Supplement 14 · standardAP
1990-07-18Manufacturing (CMC) · Supplement 11 · standardAP
1990-07-17Manufacturing (CMC) · Supplement 13 · standardAP
1989-09-21Manufacturing (CMC) · Supplement 12 · standardAP
1989-09-18Manufacturing (CMC) · Supplement 10 · standardAP
1989-07-24Manufacturing (CMC) · Supplement 9 · standardAP
1988-11-07Manufacturing (CMC) · Supplement 7 · standardAP
1988-06-02Labeling · Supplement 6AP
1987-08-25Manufacturing (CMC) · Supplement 4 · standardAP
1987-07-31Manufacturing (CMC) · Supplement 5 · standardAP
1987-06-26Manufacturing (CMC) · Supplement 3 · standardAP
1987-04-17Manufacturing (CMC) · Supplement 2 · 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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