ANDA 210200

EPIC PHARMA LLC

FDA Drug Application

Application #210200

Application Sponsors

ANDA 210200

EPIC PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

20MEQ

0

POTASSIUM CHLORIDE

POTASSIUM CHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-01-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-04-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AA

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210200
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"20MEQ","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/23\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-23
        )

)