APPLICATION
ANDA060578
TYPE
ANDA
ORIGINAL APPROVAL
1964-09-08
LATEST ACTION
1998-09-17
ROUTE
TOPICAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
MYCOSTATINDiscontinued
NYSTATIN 100,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · TOPICAL
Approval history
1998-09-17Labeling · Supplement 3AP
1992-11-30Labeling · Supplement 6AP
1992-06-19Manufacturing (CMC) · Supplement 5AP
1964-09-08OriginalAP
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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