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
CLINDESSE از شرکت PADAGIS US
New Drug Application (NDA): 050793
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDESSE | CLINDAMYCIN PHOSPHATE | EQ 2% BASE | CREAM;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/30/2004 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/18/2017 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2012 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050793s015ltr.pdf |
||
| 12/15/2010 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050793s014ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2012 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf | |
| 12/15/2010 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf | |
| 11/30/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf |
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