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FDA ANDA · ANDA074935

FLUOCINONIDE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA074935
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-29
LATEST ACTION
2004-04-16
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

FLUOCINONIDEPrescription
FLUOCINONIDE 0.05% · GEL · TOPICAL

Approval history

2004-04-16Labeling · Supplement 5AP
1998-07-27Manufacturing (CMC) · Supplement 3AP
1998-01-28Manufacturing (CMC) · Supplement 1AP
1998-01-28Manufacturing (CMC) · Supplement 2AP
1997-07-29OriginalAP
VIEW ON DRUGS@FDA ↗

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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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