APPLICATION
ANDA062524
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-26
LATEST ACTION
1993-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 500,000 UNITS · TABLET · ORAL
Approval history
1993-07-16Manufacturing (CMC) · Supplement 7AP
1992-09-11Labeling · Supplement 8AP
1985-11-26OriginalAP
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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