Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050672
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTIN | CEFUROXIME AXETIL | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | Yes | No |
| CEFTIN | CEFUROXIME AXETIL | EQ 250MG BASE/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 06/30/1994 | 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 |
|---|---|---|---|---|---|
| 03/05/2021 | SUPPL-38 | 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-37 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051; 50672Orig1s037ltr.pdf |
| 10/13/2017 | SUPPL-36 | 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-35 | 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-34 | 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-33 | 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-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf | |
| 09/20/2014 | SUPPL-29 | Labeling-Package Insert, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf | |
| 08/01/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050672s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050672s028ltr.pdf | |
| 06/03/2004 | SUPPL-25 | 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 | |
| 09/18/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-18 | 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 | |
| 09/25/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1999 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-14 | 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-13 | 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-12 | Labeling |
Label is not available on this site. |
||
| 11/19/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/08/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/27/1999 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/14/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-1 | 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-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050605s052,050672s038lbl.pdf | |
| 10/13/2017 | SUPPL-36 | 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-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf | |
| 08/26/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf | |
| 06/26/2015 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf | |
| 09/20/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf | |
| 09/20/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf | |
| 09/20/2014 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf | |
| 08/01/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050672s028lbl.pdf | |
| 06/03/2004 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf | |
| 04/11/2002 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf | |
| 03/29/2002 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf |