APPLICATION
ANDA064022
TYPE
ANDA
ORIGINAL APPROVAL
1993-01-29
LATEST ACTION
1996-09-17
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · CREAM · TOPICAL
Approval history
1996-09-17Manufacturing (CMC) · Supplement 2AP
1996-04-30Manufacturing (CMC) · Supplement 1AP
1993-01-29OriginalAP
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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