APPLICATION
ANDA062606
TYPE
ANDA
ORIGINAL APPROVAL
1985-05-15
LATEST ACTION
1995-11-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
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100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · CREAM · TOPICAL
Approval history
1995-11-30Manufacturing (CMC) · Supplement 9AP
1990-06-04Manufacturing (CMC) · Supplement 7AP
1985-05-15OriginalAP
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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