FRESENIUS KABI USA FDA Approval NDA 208418

NDA 208418

FRESENIUS KABI USA

FDA Drug Application

Application #208418

Documents

Label2017-06-16
Letter2017-06-16
Pediatric Medical Review1900-01-01
Pediatric CDTL Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Review2018-05-17
Review2018-06-05
Letter2021-06-22
Label2021-06-23
Letter2021-12-30
Label2022-01-04
Letter2022-10-18
Label2022-10-19

Application Sponsors

NDA 208418FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001SOLUTION;INTRAVENOUS1GM/10ML (100MG/ML)1CALCIUM GLUCONATECALCIUM GLUCONATE
002SOLUTION;INTRAVENOUS5GM/50ML (100MG/ML)1CALCIUM GLUCONATECALCIUM GLUCONATE
003SOLUTION;INTRAVENOUS10GM/100ML (100MG/ML)1CALCIUM GLUCONATECALCIUM GLUCONATE
004SOLUTION;INTRAVENOUS1GM/50ML (20MG/ML)1CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE
005SOLUTION;INTRAVENOUS2GM/100ML (20MG/ML)1CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDAORIG1AP2017-06-15STANDARD
LABELING; LabelingSUPPL7AP2021-06-17STANDARD
LABELING; LabelingSUPPL11AP2021-12-29STANDARD
LABELING; LabelingSUPPL13AP2022-10-17STANDARD

Submissions Property Types

ORIG1Null15
SUPPL7Null15
SUPPL11Null6
SUPPL13Null15

TE Codes

001PrescriptionAP

CDER Filings

FRESENIUS KABI USA
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(
    [0] => Array
        (
            [ApplNo] => 208418
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"5GM\/50ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"10GM\/100ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/15\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208418s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208418s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208418Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208418Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/22\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/review\\\/2018\\\/208418Orig1s001.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-12-22
        )

)

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