FRESENIUS KABI USA FDA Approval NDA 205572

NDA 205572

FRESENIUS KABI USA

FDA Drug Application

Application #205572

Documents

Letter2015-04-08
Label2015-04-10
Label2016-07-26
Summary Review2016-03-02
Letter2016-07-26
Review2016-03-02
Medication Guide2016-07-26
Label2018-10-19
Letter2018-10-23
Letter2019-05-07
Label2019-05-08
Medication Guide2019-05-08
Letter2020-03-30
Label2020-03-31
Medication Guide2020-03-31

Application Sponsors

NDA 205572FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUSEQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)1MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2015-04-03STANDARD
LABELING; LabelingSUPPL2AP2016-07-26STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL4AP2018-10-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2019-03-05N/A
LABELING; LabelingSUPPL6AP2019-05-03STANDARD
LABELING; LabelingSUPPL7AP2020-03-27STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL4Null15
SUPPL6Null7
SUPPL7Null15

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205572
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/205572s007lbl.pdf#page=49"]
            [products] => [{"drugName":"MOXIFLOXACIN HYDROCHLORIDE","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"EQ 400MG BASE\/250ML (EQ 1.6MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205572s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205572s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205572s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205572s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205572s002lbl.pdf\"}]","notes":"Please see"},{"actionDate":"04\/03\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205572s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/03\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205572s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205572Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205572Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205572Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205572s007lbl.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205572s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205572Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/05\/2019","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)-Manufacturing Process","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205572Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205572s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205572Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/26\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205572s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205572Orig1s002ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."},{"actionDate":"03\/24\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-27
        )

)

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