APPLICATION
ANDA062457
TYPE
ANDA
ORIGINAL APPROVAL
1983-07-28
LATEST ACTION
1993-08-06
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
NYSTATINDiscontinued
NYSTATIN 100,000 UNITS/GM · CREAM · TOPICAL
Approval history
1993-08-06Labeling · Supplement 20AP
1993-04-27Labeling · Supplement 21AP
1992-04-29Manufacturing (CMC) · Supplement 18AP
1992-02-24Labeling · Supplement 17AP
1989-06-30Manufacturing (CMC) · Supplement 15AP
1988-11-16Manufacturing (CMC) · Supplement 7AP
1983-07-28OriginalAP
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.