FDA NDA · NDA021112

TRI-LUMA

fluocinolone acetonide, hydroquinone, and tretinoin

Sponsor: GALDERMA LABS LP

APPLICATION

NDA021112

TYPE

NDA

ORIGINAL APPROVAL

2002-01-18

LATEST ACTION

2015-01-20

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Prescription

Products

TRI-LUMA · ReferencePrescription

FLUOCINOLONE ACETONIDE 0.01%, HYDROQUINONE 4%, TRETINOIN 0.05% · CREAM · TOPICAL

2015-01-20Manufacturing (CMC) · Supplement 11 · standardAP

2014-11-10Manufacturing (CMC) · Supplement 10 · standardAP

2014-03-31Labeling · Supplement 9 · standard — Label ↗AP

2013-10-18Manufacturing (CMC) · Supplement 8 · standardAP

2013-07-12Manufacturing (CMC) · Supplement 7 · standardAP

2013-01-16Labeling · Supplement 6 · unknown — Letter ↗AP

2002-01-18Type 4 - New Combination · Original · standard — Review ↗AP

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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