APPLICATION
ANDA060572
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-28
LATEST ACTION
1995-11-30
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
MYCOLOG-IIDiscontinued
NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
Approval history
1995-11-30Manufacturing (CMC) · Supplement 18AP
1992-11-03Labeling · Supplement 17AP
1992-03-23Manufacturing (CMC) · Supplement 15AP
1985-06-28OriginalAP
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.
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