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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021501
Company: LOREAL USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPITAL SOLEIL 15 AVOBENZONE; ECAMSULE; OCTOCRYLENE 2%;3%;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
10/02/2006 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021501s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021501_capital_soleil_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/05/2007 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021501s003ltr.pdf
04/24/2007 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021501s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/05/2007 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s003lbl.pdf
04/24/2007 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s001lbl.pdf

CAPITAL SOLEIL 15

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%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CAPITAL SOLEIL 15 AVOBENZONE; ECAMSULE; OCTOCRYLENE 2%;3%;10% CREAM;TOPICAL Over-the-counter Yes 021501 LOREAL USA
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