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FDA NDA · NDA022009

ANTHELIOS 40

Sponsor: LOREAL USA

APPLICATION
NDA022009
TYPE
NDA
ORIGINAL APPROVAL
2008-03-31
LATEST ACTION
2014-02-21
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

ANTHELIOS 40 · ReferenceOver-the-counter
AVOBENZONE 2%, ECAMSULE 3%, OCTOCRYLENE 10%, TITANIUM DIOXIDE 5% · CREAM · TOPICAL
ANTHELIOS 40 · ReferenceOver-the-counter
AVOBENZONE 2%, ECAMSULE 3%, OCTOCRYLENE 10%, TITANIUM DIOXIDE 5% · CREAM · TOPICAL

Approval history

2014-02-21Manufacturing (CMC) · Supplement 7 · standardAP
2010-04-09Labeling · Supplement 4 · unknown — Letter ↗AP
2009-10-29Efficacy · Supplement 2 · standardAP
2008-10-21Labeling · Supplement 1 · standard — Letter ↗AP
2008-03-31Type 5 - New Formulation or New Manufacturer · Original · standard — Pediatric Medical Review ↗AP
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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