APPLICATION
NDA050576
TYPE
NDA
ORIGINAL APPROVAL
1983-12-22
LATEST ACTION
1999-05-08
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
NILSTAT · ReferenceDiscontinued
NYSTATIN 100% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · ORAL
Approval history
1999-05-08Manufacturing (CMC) · Supplement 2 · standardAP
1983-12-22Type 3 - New Dosage Form · Original · 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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