APPLICATION
ANDA065183
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-03
LATEST ACTION
2007-01-18
ROUTE
TOPICAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · POWDER · TOPICAL
Approval history
2007-01-18Labeling · Supplement 8AP
2005-05-03OriginalAP
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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