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FDA ANDA · ANDA073085

FLUOCINONIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA073085
TYPE
ANDA
ORIGINAL APPROVAL
1992-02-14
LATEST ACTION
2001-07-05
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

FLUOCINONIDEPrescription
FLUOCINONIDE 0.05% · CREAM · TOPICAL

Approval history

2001-07-05Manufacturing (CMC) · Supplement 8AP
2000-12-29Manufacturing (CMC) · Supplement 7AP
1997-04-07Manufacturing (CMC) · Supplement 6AP
1997-04-07Manufacturing (CMC) · Supplement 4AP
1997-04-07Manufacturing (CMC) · Supplement 5AP
1997-04-07Manufacturing (CMC) · Supplement 3AP
1996-06-28Manufacturing (CMC) · Supplement 2AP
1993-12-22Labeling · Supplement 1AP
1992-02-14OriginalAP
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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