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FDA ANDA · ANDA062347

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA062347
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-30
LATEST ACTION
1993-04-29
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

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

Approval history

1993-04-29Labeling · Supplement 25AP
1993-04-29Labeling · Supplement 24AP
1992-11-25Labeling · Supplement 21AP
1992-11-25Labeling · Supplement 22AP
1992-02-20Labeling · Supplement 20AP
1991-12-31Manufacturing (CMC) · Supplement 16AP
1991-07-31Labeling · Supplement 19AP
1991-07-31Labeling · Supplement 15AP
1991-07-31Labeling · Supplement 14AP
1989-07-24Manufacturing (CMC) · Supplement 11AP
1989-07-24Manufacturing (CMC) · Supplement 12AP
1989-06-30Manufacturing (CMC) · Supplement 13AP
1989-05-10Manufacturing (CMC) · Supplement 10AP
1988-11-15Manufacturing (CMC) · Supplement 9AP
1987-03-30OriginalAP
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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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