APPLICATION
ANDA062876
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-29
LATEST ACTION
2007-07-23
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL
Approval history
2007-07-23Manufacturing (CMC) · Supplement 13AP
1996-11-04Labeling · Supplement 10AP
1989-07-10Manufacturing (CMC) · Supplement 7AP
1989-06-30Manufacturing (CMC) · Supplement 6AP
1989-05-10Manufacturing (CMC) · Supplement 5AP
1988-02-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.