Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050703
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BACTROBAN | MUPIROCIN CALCIUM | EQ 2% BASE | OINTMENT;NASAL | 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 |
---|---|---|---|---|---|---|---|
09/18/1995 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
---|---|---|---|---|---|
02/19/2020 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050703s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050703Orig1s018ltr.pdf | |
05/08/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050703s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050703ORig1s017ltr.pdf | |
05/14/2015 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050703s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050703Orig1s016ltr.pdf | |
05/22/2014 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
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 | |
11/15/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/09/2001 | 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. |
||
10/06/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/19/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/04/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/20/1995 | 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 |
---|---|---|---|---|---|
02/19/2020 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050703s018lbl.pdf | |
02/19/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050703s018lbl.pdf | |
05/08/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050703s017lbl.pdf | |
05/14/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050703s016lbl.pdf | |
05/22/2014 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf |