Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050658
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIMENTIN IN PLASTIC CONTAINER | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | EQ 100MG BASE/100ML;EQ 3GM BASE/100ML | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/15/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 06/12/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658Orig1s031ltr.pdf | |
| 05/14/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658Orig1s029ltr.pdf | |
| 05/29/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2012 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050590Orig1s062,050658Orig1s025ltr.pdf | |
| 06/09/2011 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050658s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf | |
| 12/20/2010 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf | |
| 04/17/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050658s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050658s022ltr.pdf | |
| 05/08/2008 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s055, 050658s021ltr.pdf |
| 03/15/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050590s054,050658s020ltr.pdf | |
| 11/19/2004 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50590s052,50658s018ltr.pdf |
| 01/03/2003 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/2002 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590s40ltr.pdf |
| 11/19/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1999 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/15/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/22/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/12/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf | |
| 09/27/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf | |
| 10/04/2012 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf | |
| 06/09/2011 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050658s024lbl.pdf | |
| 12/20/2010 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf | |
| 04/17/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050658s022lbl.pdf | |
| 03/15/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf |