APPLICATION
ANDA062517
TYPE
ANDA
ORIGINAL APPROVAL
1984-06-07
LATEST ACTION
2004-12-14
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
2004-12-14Labeling · Supplement 9AP
2004-12-13Labeling · Supplement 6AP
1999-01-26Manufacturing (CMC) · Supplement 5AP
1998-06-11Labeling · Supplement 4AP
1995-06-23Manufacturing (CMC) · Supplement 3AP
1993-09-27Labeling · Supplement 2AP
1984-06-07OriginalAP
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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