APPLICATION
ANDA062512
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-29
LATEST ACTION
2002-03-20
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
NYSTATINPrescription
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
2002-03-20Manufacturing (CMC) · Supplement 16AP
1997-07-11Labeling · Supplement 15AP
1996-09-03Labeling · Supplement 14AP
1994-10-20Manufacturing (CMC) · Supplement 13AP
1994-09-30Manufacturing (CMC) · Supplement 12AP
1994-03-11Labeling · Supplement 11AP
1992-03-25Manufacturing (CMC) · Supplement 10AP
1989-01-10Manufacturing (CMC) · Supplement 9AP
1984-10-29OriginalAP
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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