APPLICATION
ANDA062615
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-17
LATEST ACTION
2001-05-24
ROUTE
VAGINAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 100,000 UNITS · TABLET · VAGINAL
Approval history
2001-05-24Manufacturing (CMC) · Supplement 7AP
2000-07-07Manufacturing (CMC) · Supplement 5AP
1995-10-05Manufacturing (CMC) · Supplement 4AP
1994-05-11Manufacturing (CMC) · Supplement 3AP
1991-12-09Manufacturing (CMC) · Supplement 2AP
1986-06-13Manufacturing (CMC) · Supplement 1AP
1985-10-17OriginalAP
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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