BAXTER HLTHCARE CORP FDA Approval NDA 207026

NDA 207026

BAXTER HLTHCARE CORP

FDA Drug Application

Application #207026

Documents

Letter2015-01-15
Letter2015-12-17
Label2015-12-17
Label2016-07-21
Letter2016-07-22
Label2015-01-14
Review2015-04-07
Summary Review2015-04-07
Label2017-07-03
Letter2017-07-05
Label2018-12-06
Letter2018-11-06

Application Sponsors

NDA 207026BAXTER HLTHCARE CORP

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)1PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINERCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
002INJECTABLE;INJECTIONN/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)1PHOXILLUM B22K 4/0 IN PLASTIC CONTAINERCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2015-01-13STANDARD
LABELING; LabelingSUPPL2AP2016-07-20STANDARD
LABELING; LabelingSUPPL4AP2017-06-30STANDARD
LABELING; LabelingSUPPL6AP2018-11-01STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL2Null6
SUPPL4Orphan5
SUPPL6Null15

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207026
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHOXILLUM B22K 4\/0 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE","strength":"N\/A\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML;2.21GM\/1000ML;6.95GM\/1000ML;0.187GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PHOXILLUM BK 4\/2.5 IN PLASTIC CONTAINER","activeIngredients":"CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE","strength":"3.68GM\/1000ML;3.05GM\/1000ML;0.314GM\/1000ML ;3.09GM\/1000ML;6.34GM\/1000ML;0.187GM\/1000ML (5000ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/01\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"11\/01\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/30\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021703s018,207026s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021703s017,207026s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021703s016-207026s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207026s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/13\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207026s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207026Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207026Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207026Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/01\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/021703Orig1s020,207026Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/30\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021703s018,207026s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/21703Orig1s018,207026Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/20\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021703s017,207026s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/021703Orig1s017,207026Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"12\/15\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021703s016-207026s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/021703Orig1s016,207026Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-11-01
        )

)

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