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
CAPEX از شرکت GALDERMA LABS LP
New Drug Application (NDA): 020001
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPEX | FLUOCINOLONE ACETONIDE | 0.01% | SHAMPOO;TOPICAL | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 08/27/1990 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020001Orig1s012ltr.pdf |
|
| 07/06/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/19/1991 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/24/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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