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FDA ANDA · ANDA072537

FLUOCINONIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA072537
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-07
LATEST ACTION
2017-10-23
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

FLUOCINONIDEDiscontinued
FLUOCINONIDE 0.05% · GEL · TOPICAL

Approval history

2017-10-23Manufacturing (CMC) · Supplement 26 · unknownAP
2001-08-30Manufacturing (CMC) · Supplement 18AP
2001-02-26Manufacturing (CMC) · Supplement 16AP
2000-07-07Manufacturing (CMC) · Supplement 17AP
2000-02-17Manufacturing (CMC) · Supplement 15AP
1997-03-27Labeling · Supplement 14AP
1996-10-17Labeling · Supplement 9AP
1996-08-08Manufacturing (CMC) · Supplement 13AP
1996-08-08Manufacturing (CMC) · Supplement 11AP
1996-08-08Manufacturing (CMC) · Supplement 12AP
1996-06-13Manufacturing (CMC) · Supplement 10AP
1996-04-09Manufacturing (CMC) · Supplement 8AP
1995-05-04Manufacturing (CMC) · Supplement 6AP
1995-05-04Manufacturing (CMC) · Supplement 7AP
1993-08-31Manufacturing (CMC) · Supplement 4AP
1993-08-31Manufacturing (CMC) · Supplement 5AP
1993-06-30Manufacturing (CMC) · Supplement 3AP
1992-09-01Manufacturing (CMC) · Supplement 1AP
1989-02-07OriginalAP
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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