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
AKTIPAK از شرکت BIOFRONTERA
New Drug Application (NDA): 050769
Company: BIOFRONTERA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AKTIPAK | BENZOYL PEROXIDE; ERYTHROMYCIN | 5%;3% | GEL;TOPICAL | Discontinued |
None |
Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/27/2000 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-769_Benamycin.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/29/2016 | SUPPL-17 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050769s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050769Orig1s017ltr.pdf |
||
| 03/16/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/2001 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/17/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/29/2016 | SUPPL-17 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050769s017lbl.pdf |
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