APPLICATION
ANDA062124
TYPE
ANDA
ORIGINAL APPROVAL
1982-09-23
LATEST ACTION
2002-09-19
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · OINTMENT · TOPICAL
Approval history
2002-09-19Manufacturing (CMC) · Supplement 7AP
2001-12-06Manufacturing (CMC) · Supplement 8AP
1996-03-25Manufacturing (CMC) · Supplement 5AP
1996-03-07Manufacturing (CMC) · Supplement 6AP
1994-03-11Labeling · Supplement 2AP
1994-03-11Manufacturing (CMC) · Supplement 1AP
1994-01-06Labeling · Supplement 4AP
1993-06-03Labeling · Supplement 3AP
1982-09-23OriginalAP
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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