APPLICATION
ANDA062613
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-26
LATEST ACTION
2002-03-26
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 100% · POWDER · ORAL
Approval history
2002-03-26Manufacturing (CMC) · Supplement 9AP
1996-12-27Manufacturing (CMC) · Supplement 8AP
1995-07-11Manufacturing (CMC) · Supplement 7AP
1995-02-03Labeling · Supplement 2AP
1995-02-03Labeling · Supplement 1AP
1994-10-18Manufacturing (CMC) · Supplement 3AP
1993-08-04Manufacturing (CMC) · Supplement 5AP
1993-07-16Manufacturing (CMC) · Supplement 4AP
1993-05-28Manufacturing (CMC) · Supplement 6AP
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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