APPLICATION
ANDA061954
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-20
LATEST ACTION
2001-08-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
MYCO-TRIACET IIDiscontinued
NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% · CREAM · TOPICAL
Approval history
2001-08-30Manufacturing (CMC) · Supplement 35AP
1997-08-19Manufacturing (CMC) · Supplement 34AP
1996-10-31Manufacturing (CMC) · Supplement 33AP
1996-06-13Manufacturing (CMC) · Supplement 32AP
1996-04-12Manufacturing (CMC) · Supplement 31AP
1995-07-05Manufacturing (CMC) · Supplement 28AP
1995-07-05Manufacturing (CMC) · Supplement 30AP
1995-07-05Manufacturing (CMC) · Supplement 29AP
1995-06-30Manufacturing (CMC) · Supplement 27AP
1995-05-04Manufacturing (CMC) · Supplement 25AP
1995-05-04Manufacturing (CMC) · Supplement 26AP
1995-02-15Manufacturing (CMC) · Supplement 24AP
1993-12-03Manufacturing (CMC) · Supplement 23AP
1993-12-03Manufacturing (CMC) · Supplement 21AP
1993-12-03Manufacturing (CMC) · Supplement 22AP
1993-12-03Manufacturing (CMC) · Supplement 20AP
1993-10-21Manufacturing (CMC) · Supplement 15AP
1993-10-21Manufacturing (CMC) · Supplement 13AP
1993-10-21Manufacturing (CMC) · Supplement 16AP
1993-10-21Manufacturing (CMC) · Supplement 14AP
1993-08-31Manufacturing (CMC) · Supplement 19AP
1993-08-31Manufacturing (CMC) · Supplement 17AP
1993-08-31Manufacturing (CMC) · Supplement 18AP
1993-08-10Manufacturing (CMC) · Supplement 11AP
1993-08-04Labeling · Supplement 12AP
1992-01-13Manufacturing (CMC) · Supplement 10AP
1989-07-26Manufacturing (CMC) · Supplement 9AP
1988-12-16Manufacturing (CMC) · Supplement 7AP
1985-09-20OriginalAP
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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