APPLICATION
ANDA062225
TYPE
ANDA
ORIGINAL APPROVAL
1979-12-11
LATEST ACTION
2009-12-03
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · CREAM · TOPICAL
Approval history
2009-12-03Labeling · Supplement 11AP
2009-04-17Labeling · Supplement 10AP
2000-09-05Manufacturing (CMC) · Supplement 8AP
1995-06-15Manufacturing (CMC) · Supplement 6AP
1995-06-15Manufacturing (CMC) · Supplement 7AP
1994-07-06Labeling · Supplement 4AP
1993-10-04Labeling · Supplement 5AP
1988-03-18Manufacturing (CMC) · Supplement 3AP
1979-12-11OriginalAP
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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