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FDA ANDA · ANDA062367

MYKACET

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA062367
TYPE
ANDA
ORIGINAL APPROVAL
1985-05-28
LATEST ACTION
2001-05-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

MYKACETDiscontinued
NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% · CREAM · TOPICAL

Approval history

2001-05-30Manufacturing (CMC) · Supplement 21AP
2000-12-29Manufacturing (CMC) · Supplement 20AP
1998-10-16Manufacturing (CMC) · Supplement 18AP
1997-04-18Manufacturing (CMC) · Supplement 17AP
1997-04-18Manufacturing (CMC) · Supplement 15AP
1997-04-18Manufacturing (CMC) · Supplement 13AP
1997-04-18Manufacturing (CMC) · Supplement 16AP
1997-04-18Manufacturing (CMC) · Supplement 14AP
1996-06-28Manufacturing (CMC) · Supplement 12AP
1996-02-07Manufacturing (CMC) · Supplement 11AP
1995-02-10Manufacturing (CMC) · Supplement 9AP
1995-02-10Manufacturing (CMC) · Supplement 10AP
1994-12-28Manufacturing (CMC) · Supplement 8AP
1993-12-22Manufacturing (CMC) · Supplement 6AP
1993-12-22Manufacturing (CMC) · Supplement 4AP
1993-12-22Labeling · Supplement 5AP
1993-02-11Manufacturing (CMC) · Supplement 7AP
1985-05-28OriginalAP
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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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