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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021471
Company: LOREAL USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTHELIOS 20 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE 2%;2%;10%;2% CREAM;TOPICAL Over-the-counter None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/05/2006 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021471lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021471s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021471s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
01/17/2008 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021471s004ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/05/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021471lbl.pdf

ANTHELIOS 20

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CREAM;TOPICAL; 2%;2%;10%;2%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ANTHELIOS 20 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE 2%;2%;10%;2% CREAM;TOPICAL Over-the-counter Yes 021471 LOREAL USA
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