APPLICATION
ANDA062045
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-26
LATEST ACTION
2001-08-30
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
MYCO-TRIACET IIDiscontinued
NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% · OINTMENT · TOPICAL
Approval history
2001-08-30Manufacturing (CMC) · Supplement 17AP
1997-08-19Manufacturing (CMC) · Supplement 16AP
1996-06-13Manufacturing (CMC) · Supplement 15AP
1996-04-12Manufacturing (CMC) · Supplement 14AP
1993-12-03Manufacturing (CMC) · Supplement 13AP
1993-12-03Manufacturing (CMC) · Supplement 12AP
1993-08-31Manufacturing (CMC) · Supplement 11AP
1993-08-04Labeling · Supplement 10AP
1992-11-09Manufacturing (CMC) · Supplement 9AP
1985-11-26OriginalAP
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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