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FDA NDA · NDA021471

ANTHELIOS 20

Sponsor: LOREAL USA

APPLICATION
NDA021471
TYPE
NDA
ORIGINAL APPROVAL
2006-10-05
LATEST ACTION
2014-02-21
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

ANTHELIOS 20 · ReferenceOver-the-counter
AVOBENZONE 2%, ECAMSULE 2%, OCTOCRYLENE 10%, TITANIUM DIOXIDE 2% · CREAM · TOPICAL

Approval history

2014-02-21Manufacturing (CMC) · Supplement 8 · standardAP
2008-01-17Labeling · Supplement 4 · standard — Letter ↗AP
2006-10-05Type 4 - New Combination · Original · standard — Label ↗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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