APPLICATION
ANDA062065
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-16
LATEST ACTION
1996-02-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 500,000 UNITS · TABLET · ORAL
Approval history
1996-02-12Labeling · Supplement 14AP
1996-02-12Labeling · Supplement 10AP
1995-08-29Manufacturing (CMC) · Supplement 15AP
1995-06-13Manufacturing (CMC) · Supplement 12AP
1995-01-27Manufacturing (CMC) · Supplement 11AP
1994-10-27Manufacturing (CMC) · Supplement 13AP
1994-09-16OriginalAP
1992-09-11Labeling · Supplement 9AP
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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