LUPIN LTD FDA Approval NDA 203195

NDA 203195

LUPIN LTD

FDA Drug Application

Application #203195

Documents

Letter2012-06-07
Letter2016-01-11
Label2013-04-01
Label2012-06-05
Label2016-01-12
Review2012-11-16
Summary Review2012-11-16
Label2017-03-17
Letter2017-03-20
Letter2018-03-29
Label2018-04-01

Application Sponsors

NDA 203195LUPIN LTD

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL400MG1SUPRAXCEFIXIME

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2012-06-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2013-09-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2013-11-22STANDARD
LABELING; LabelingSUPPL5AP2016-01-07STANDARD
LABELING; LabelingSUPPL6AP2017-03-16STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL8AP2018-03-30STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null0
SUPPL3Null0
SUPPL5Null15
SUPPL6Null15
SUPPL8Null15

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203195
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUPRAX","activeIngredients":"CEFIXIME","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/30\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202091S007_203195_S008lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202091s005,203195s006lbl.pdf\"}]","notes":"Please see"},{"actionDate":"01\/07\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202091s004,203195s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203195s001lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/01\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203195s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/01\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203195s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203195s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203195_suprax_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203195Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/30\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202091S007_203195_S008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202091Orig1s007,203195Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/16\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202091s005,203195s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203195Orig1s006,202091Orig1s005ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."},{"actionDate":"01\/07\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202091s004,203195s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202091Orig1s004,203195Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/22\/2013","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/26\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203195s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2018-03-30
        )

)

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