Documents
Application Sponsors
| NDA 050605 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CEFTIN | CEFUROXIME AXETIL |
| 002 | TABLET;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CEFTIN | CEFUROXIME AXETIL |
| 003 | TABLET;ORAL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CEFTIN | CEFUROXIME AXETIL |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 1987-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1991-08-19 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1991-08-19 | |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 1996-03-13 | |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 1992-01-31 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1991-08-19 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1993-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1991-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1993-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1992-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1993-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1993-06-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 1996-12-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 19 | AP | 1994-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1995-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1996-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 1996-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 1996-09-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 1996-12-06 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 1997-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1996-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 1997-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1997-11-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1998-01-16 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 1998-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2002-03-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 32 | AP | 1999-08-24 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2002-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2001-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2001-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2001-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2002-07-24 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2004-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2007-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2014-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2014-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2015-06-26 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2015-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2016-11-22 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2017-10-13 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 51 | AP | 2019-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2021-03-05 | STANDARD |
Submissions Property Types
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 43 | Null | 6 |
| SUPPL | 46 | Null | 7 |
| SUPPL | 47 | Null | 15 |
| SUPPL | 48 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 50 | Null | 6 |
| SUPPL | 51 | Null | 33 |
| SUPPL | 52 | Null | 7 |
CDER Filings
GLAXOSMITHKLINE
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[companyName] => GLAXOSMITHKLINE
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[labels] => [{"actionDate":"04\/25\/2019","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050605s051,050672s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2019","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050605s051,050672s037lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2017","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050605s050,050672s036lbl.pdf\"}]","notes":"Please see"},{"actionDate":"11\/22\/2016","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050605s049,050672s035lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2015","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050605s048,050672s034lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2015","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050605s047,050672s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2014","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050605s043s046lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050605s043s046lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2014","submission":"SUPPL-43","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050605s043s046lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2007","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050605s042lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2004","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50605slr039,50672slr025_ceftin_lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2002","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50605s33lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2002","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50605s31lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CEFTIN","submission":"CEFUROXIME AXETIL","actionType":"EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CEFTIN","submission":"CEFUROXIME AXETIL","actionType":"EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CEFTIN","submission":"CEFUROXIME AXETIL","actionType":"EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-04-25
)
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