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FDA NDA · NDA019561

MICRO-K LS

Sponsor: KV PHARM

APPLICATION
NDA019561
TYPE
NDA
ORIGINAL APPROVAL
1988-08-26
LATEST ACTION
2005-08-22
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MICRO-K LS · ReferenceDiscontinued
POTASSIUM CHLORIDE 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2005-08-22Labeling · Supplement 4 · standardLetterAP
1998-01-13Manufacturing (CMC) · Supplement 1 · standardAP
1988-08-26Type 3 - New Dosage Form · Original · standardReviewAP
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