ANDA 211067

APOTEX

FDA Drug Application

Application #211067

Documents

• Letter: 2018-08-16

Application Sponsors

ANDA 211067

APOTEX

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	20MEQ/15ML	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE
002	SOLUTION;ORAL	40MEQ/15ML	0	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-08-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-03-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211067
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"40MEQ\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/08\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211067Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/30\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-30
        )

)