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FDA ANDA · ANDA070999

K+10

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APPLICATION
ANDA070999
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-22
LATEST ACTION
1995-06-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

K+10Discontinued
POTASSIUM CHLORIDE 10MEQ · TABLET, EXTENDED RELEASE · ORAL

Approval history

1995-06-23Manufacturing (CMC) · Supplement 6AP
1995-06-23Manufacturing (CMC) · Supplement 7AP
1994-07-22Manufacturing (CMC) · Supplement 5AP
1992-11-16Bioequivalence · Supplement 4AP
1987-10-22OriginalAP
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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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