APPLICATION
ANDA060574
TYPE
ANDA
ORIGINAL APPROVAL
1964-09-16
LATEST ACTION
1996-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MYCOSTATINDiscontinued
NYSTATIN 500,000 UNITS · TABLET · ORAL
Approval history
1996-04-11Labeling · Supplement 13AP
1995-11-27Manufacturing (CMC) · Supplement 14AP
1992-12-07Labeling · Supplement 12AP
1992-06-23Manufacturing (CMC) · Supplement 11AP
1964-09-16OriginalAP
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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