APPLICATION
ANDA062129
TYPE
ANDA
ORIGINAL APPROVAL
1979-02-01
LATEST ACTION
2016-02-03
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · CREAM · TOPICAL
Approval history
2016-02-03Labeling · Supplement 10 · standardAP
2002-09-19Manufacturing (CMC) · Supplement 4AP
2002-03-08Manufacturing (CMC) · Supplement 5AP
1996-03-07Manufacturing (CMC) · Supplement 2AP
1995-07-05Manufacturing (CMC) · Supplement 1AP
1979-02-01OriginalAP
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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