Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022009
Company: LOREAL USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTHELIOS 40 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE 2%;3%;10%;5% CREAM;TOPICAL Over-the-counter None Yes Yes
ANTHELIOS 40 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE 2%;3%;10%;5% 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
03/31/2008 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009_avobenzone_ecamsule_octocrylene_titanium_dioxide_cream_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/09/2010 SUPPL-4 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022009s004ltr.pdf
10/29/2009 SUPPL-2 Efficacy-Manufacturing Change With Clinical Data

Label is not available on this site.

10/21/2008 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s001ltr.pdf

ANTHELIOS 40

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%;3%;10%;5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ANTHELIOS 40 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE 2%;3%;10%;5% CREAM;TOPICAL Over-the-counter Yes 022009 LOREAL USA

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%;3%;10%;5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ANTHELIOS 40 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE 2%;3%;10%;5% CREAM;TOPICAL Over-the-counter Yes 022009 LOREAL USA

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