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FDA ANDA · ANDA089526

FLUOCINOLONE ACETONIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA089526
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-26
LATEST ACTION
1993-01-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.01% · CREAM · TOPICAL

Approval history

1993-01-25Manufacturing (CMC) · Supplement 2AP
1993-01-25Manufacturing (CMC) · Supplement 1AP
1988-07-26OriginalAP
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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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