APPLICATION
ANDA062838
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-22
LATEST ACTION
2002-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 500,000 UNITS · TABLET · ORAL
Approval history
2002-06-28Manufacturing (CMC) · Supplement 10AP
2001-10-30Manufacturing (CMC) · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
2000-05-16Manufacturing (CMC) · Supplement 7AP
1998-01-30Labeling · Supplement 5AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-02-24Manufacturing (CMC) · Supplement 4AP
1995-06-22Manufacturing (CMC) · Supplement 3AP
1994-04-15Labeling · Supplement 2AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1988-12-22OriginalAP
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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