GLAXOSMITHKLINE FDA Approval NDA 050672

NDA 050672

GLAXOSMITHKLINE

FDA Drug Application

Application #050672

Documents

Letter2002-03-29
Letter2007-08-02
Label2002-03-29
Label2002-04-11
Label2015-08-27
Review1999-08-24
Letter1999-08-24
Letter2002-04-11
Letter2004-06-07
Letter2014-09-23
Letter2014-09-23
Letter2015-07-07
Letter2015-08-28
Label2004-06-07
Label2007-08-02
Label2014-09-22
Label2014-09-22
Label2015-07-01
Letter2016-11-23
Label2016-12-01
Label2017-10-17
Letter2017-10-18
Letter2019-04-26
Letter2021-03-09
Label2021-03-09

Application Sponsors

NDA 050672GLAXOSMITHKLINE

Marketing Status

Discontinued001
Discontinued002

Application Products

001FOR SUSPENSION;ORALEQ 125MG BASE/5ML1CEFTINCEFUROXIME AXETIL
002FOR SUSPENSION;ORALEQ 250MG BASE/5ML1CEFTINCEFUROXIME AXETIL

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1994-06-30STANDARD
LABELING; LabelingSUPPL2AP1995-12-14
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-07-27STANDARD
LABELING; LabelingSUPPL4AP1996-12-23STANDARD
LABELING; LabelingSUPPL5AP1996-09-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1995-08-08STANDARD
LABELING; LabelingSUPPL7AP1995-11-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1997-04-29STANDARD
LABELING; LabelingSUPPL9AP1996-12-23STANDARD
LABELING; LabelingSUPPL10AP1997-06-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1997-11-19STANDARD
LABELING; LabelingSUPPL12AP1998-03-24STANDARD
LABELING; LabelingSUPPL13AP2002-03-29STANDARD
EFFICACY; EfficacySUPPL14AP1999-08-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1999-03-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1999-04-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-09-25STANDARD
LABELING; LabelingSUPPL18AP2002-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2001-07-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2001-04-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2001-09-18STANDARD
LABELING; LabelingSUPPL25AP2004-06-03STANDARD
LABELING; LabelingSUPPL28AP2007-08-01STANDARD
LABELING; LabelingSUPPL29AP2014-09-20STANDARD
LABELING; LabelingSUPPL32AP2014-09-20STANDARD
LABELING; LabelingSUPPL33AP2015-06-26STANDARD
LABELING; LabelingSUPPL34AP2015-08-26STANDARD
LABELING; LabelingSUPPL35AP2016-11-22STANDARD
LABELING; LabelingSUPPL36AP2017-10-13STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL37AP2019-04-25STANDARD
LABELING; LabelingSUPPL38AP2021-03-05STANDARD

Submissions Property Types

SUPPL3Null0
SUPPL6Null0
SUPPL8Null0
SUPPL11Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL29Null15
SUPPL32Null7
SUPPL33Null15
SUPPL34Null6
SUPPL35Null6
SUPPL36Null6
SUPPL37Null33
SUPPL38Null7

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50672
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTIN","activeIngredients":"CEFUROXIME AXETIL","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CEFTIN","activeIngredients":"CEFUROXIME AXETIL","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/13\/2017","submission":"SUPPL-36","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-35","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-34","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-33","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-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050672s029s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2014","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050672s029s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050672s029s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2007","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050672s028lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2004","submission":"SUPPL-25","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-18","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-13","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\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CEFTIN","submission":"CEFUROXIME AXETIL","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-10-13
        )

)
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