Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021501
Company: LOREAL USA
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 |