NDA 212832

FRESENIUS KABI USA

FDA Drug Application

Application #212832

Documents

• Label: 2019-11-27
• Letter: 2019-11-27
• Review: 2020-05-04

Application Sponsors

NDA 212832

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	1	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
002	SOLUTION;INTRAVENOUS	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	1	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
003	SOLUTION;INTRAVENOUS	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	1	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-11-26

PRIORITY

Submissions Property Types

ORIG

1

Null

40

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 212832
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM PHOSPHATES","activeIngredients":"POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC","strength":"1.18GM\/5ML (236MG\/ML);1.12GM\/5ML (224MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM PHOSPHATES","activeIngredients":"POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC","strength":"3.54GM\/15ML (236MG\/ML);3.36GM\/15ML (224MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"POTASSIUM PHOSPHATES","activeIngredients":"POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC","strength":"11.8GM\/50ML (236MG\/ML);11.2GM\/50ML (224MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/26\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212832s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212832s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212832Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212832Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-11-26
        )

)