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FDA ANDA · ANDA085539

FLUTEX

Sponsor: IVAX PHARMS

APPLICATION
ANDA085539
TYPE
ANDA
ORIGINAL APPROVAL
1978-06-23
LATEST ACTION
1990-12-11
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

FLUTEXDiscontinued
TRIAMCINOLONE ACETONIDE 0.5% · CREAM · TOPICAL
FLUTEXDiscontinued
TRIAMCINOLONE ACETONIDE 0.025% · CREAM · TOPICAL
FLUTEXDiscontinued
TRIAMCINOLONE ACETONIDE 0.1% · CREAM · TOPICAL

Approval history

1990-12-11Labeling · Supplement 8AP
1978-06-23OriginalAP
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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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