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): 050591
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTROBAN | MUPIROCIN | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT;TOPICAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/31/1987 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 05/08/2017 | SUPPL-34 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050591s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050591Orig1s034ltr.pdf |
||
| 12/14/2015 | SUPPL-33 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s033lbl.pdf |
||
| 05/22/2014 | SUPPL-32 | 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-30 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050591Orig1s030ltr.pdf |
||
| 11/09/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/19/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50591s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50591S022_Bactroban.pdf |
|
| 12/03/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1993 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/24/1994 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/24/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/30/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/08/2017 | SUPPL-34 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050591s034lbl.pdf | |
| 12/14/2015 | SUPPL-33 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s033lbl.pdf | |
| 03/19/2015 | SUPPL-30 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s030lbl.pdf | |
| 05/22/2014 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf |
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