APPLICATION
ANDA062597
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-08
LATEST ACTION
1996-03-07
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
MYTREX FDiscontinued
NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% · CREAM · TOPICAL
Approval history
1996-03-07Manufacturing (CMC) · Supplement 3AP
1995-07-25Manufacturing (CMC) · Supplement 2AP
1994-04-25Labeling · Supplement 1AP
1985-10-08OriginalAP
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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