NDA 212121

CMP DEV LLC

FDA Drug Application

Application #212121

Documents

• Label: 2019-09-20
• Letter: 2019-09-20
• Review: 2020-05-04

Application Sponsors

NDA 212121

CMP DEV LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)

1

POTASSIUM PHOSPHATES

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-09-19

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

CMP DEV LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212121
            [companyName] => CMP DEV LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM PHOSPHATES","activeIngredients":"POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC","strength":"4.5GM\/15ML (300MG\/ML);2.65GM\/15ML (175MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/19\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212121s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/19\/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\\\/212121s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212121Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212121Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-09-19
        )

)