APPLICATION
ANDA062472
TYPE
ANDA
ORIGINAL APPROVAL
1984-02-13
LATEST ACTION
2009-04-17
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · OINTMENT · TOPICAL
Approval history
2009-04-17Labeling · Supplement 4AP
2000-09-05Manufacturing (CMC) · Supplement 2AP
1994-04-06Labeling · Supplement 1AP
1984-02-13OriginalAP
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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