اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CAPITAL SOLEIL 15 از شرکت LOREAL USA
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 |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021501s000LTR.pdf |
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 |
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 |
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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