FDA NDA · NDA021502

ANTHELIOS SX

Sponsor: LOREAL USA

APPLICATION

NDA021502

TYPE

NDA

ORIGINAL APPROVAL

2006-07-21

LATEST ACTION

2014-02-21

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Over-the-counter

Products

ANTHELIOS SX · ReferenceOver-the-counter

AVOBENZONE 2%, ECAMSULE 2%, OCTOCRYLENE 10% · CREAM · TOPICAL

2014-02-21Manufacturing (CMC) · Supplement 14 · standardAP

2013-08-27Manufacturing (CMC) · Supplement 13 · standardAP

2007-03-14Labeling · Supplement 6 · standard — Letter ↗AP

2007-01-12Labeling · Supplement 4 · standard — Label ↗AP

2006-12-14Labeling · Supplement 1 · standard — Review ↗AP

2006-12-13Labeling · Supplement 3 · standard — Letter ↗AP

2006-12-12Labeling · Supplement 2 · standard — Label ↗AP

2006-07-21Type 1 - New Molecular Entity and Type 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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