Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050605
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTIN | CEFUROXIME AXETIL | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CEFTIN | CEFUROXIME AXETIL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CEFTIN | CEFUROXIME AXETIL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/28/1987 | 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 |
|---|---|---|---|---|---|
| 03/05/2021 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050605s052,050672s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050605Orig1s052; 050672Orig1s038ltr.pdf | |
| 04/25/2019 | SUPPL-51 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050605s051,050672s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051; 50672Orig1s037ltr.pdf | |
| 10/13/2017 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050605Orig1s050,050672Orig1s36ltr.pdf |
| 11/22/2016 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050605Orig1s049,050672Orig1s035ltr.pdf | |
| 08/26/2015 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf | |
| 06/26/2015 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf | |
| 09/20/2014 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf | |
| 09/20/2014 | SUPPL-43 | Labeling-Package Insert, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf | |
| 07/23/2007 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050605s042ltr.pdf | |
| 06/03/2004 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf | |
| 07/24/2002 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605slr037ltr.pdf |
| 12/20/2001 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/2001 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/2001 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf | |
| 08/24/1999 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf |
| 03/29/2002 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf | |
| 03/24/1998 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1997 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/17/1997 | SUPPL-25 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 12/06/1996 | SUPPL-24 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/19/1996 | SUPPL-17 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/28/1993 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/09/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/19/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/13/1996 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/19/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/19/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/05/2021 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050605s052,050672s038lbl.pdf | |
| 04/25/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050605s051,050672s037lbl.pdf | |
| 04/25/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050605s051,050672s037lbl.pdf | |
| 10/13/2017 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050605s050,050672s036lbl.pdf |
| 11/22/2016 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf | |
| 08/26/2015 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf | |
| 06/26/2015 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf | |
| 09/20/2014 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf | |
| 09/20/2014 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf | |
| 09/20/2014 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf | |
| 07/23/2007 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf | |
| 06/03/2004 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf | |
| 04/11/2002 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf | |
| 03/29/2002 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf |