Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021502
Company: LOREAL USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTHELIOS SX AVOBENZONE; ECAMSULE; OCTOCRYLENE 2%;2%;10% 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
07/21/2006 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021502s000_AntheliosTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2014 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/27/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/14/2007 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021502s006ltr.pdf
01/12/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s004_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021502s004ltr.pdf
12/13/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s003ltr.pdf
12/12/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s002ltr.pdf
12/14/2006 SUPPL-1 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021502s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/14/2007 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s006lbl.pdf
01/12/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s004_LBL.pdf
12/13/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s003lbl.pdf
12/12/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s002lbl.pdf

ANTHELIOS SX

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%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ANTHELIOS SX AVOBENZONE; ECAMSULE; OCTOCRYLENE 2%;2%;10% CREAM;TOPICAL Over-the-counter Yes 021502 LOREAL USA

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