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FDA ANDA · ANDA062599

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Sponsor: FOUGERA PHARMS INC

APPLICATION
ANDA062599
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-08
LATEST ACTION
2002-03-14
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

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

Approval history

2002-03-14Manufacturing (CMC) · Supplement 18AP
1996-03-07Manufacturing (CMC) · Supplement 14AP
1995-07-27Manufacturing (CMC) · Supplement 12AP
1993-06-18Labeling · Supplement 11AP
1993-04-28Labeling · Supplement 10AP
1989-07-18Manufacturing (CMC) · Supplement 9AP
1985-10-08OriginalAP
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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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