ANDA 210902

AMNEAL PHARMS LLC

FDA Drug Application

Application #210902

Application Sponsors

ANDA 210902

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

20MEQ

0

POTASSIUM CHLORIDE

POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-05-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-06-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210902
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/19\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/23\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-19
        )

)