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
BACTROBAN از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 050746
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTROBAN | MUPIROCIN CALCIUM | EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM;TOPICAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/11/1997 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050746_bactroban_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/19/2020 | SUPPL-22 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050746s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050746Orig1s022ltr.pdf |
||
| 05/08/2017 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050746s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050746Orig1s021ltr.pdf |
||
| 12/14/2015 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s020ltr.pdf |
||
| 12/16/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/2014 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf |
||
| 03/19/2015 | SUPPL-13 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s013ltr.pdf |
||
| 11/15/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1998 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/19/2020 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050746s022lbl.pdf | |
| 02/19/2020 | SUPPL-22 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050746s022lbl.pdf | |
| 05/08/2017 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050746s021lbl.pdf | |
| 12/14/2015 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s020lbl.pdf | |
| 03/19/2015 | SUPPL-13 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s013lbl.pdf | |
| 05/22/2014 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf |
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