ANDA 206203

EXELA PHARMA SCS LLC

FDA Drug Application

Application #206203

Application Sponsors

ANDA 206203

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MEQ/ML

0

POTASSIUM ACETATE

POTASSIUM ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2017-10-25

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206203
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM ACETATE","activeIngredients":"POTASSIUM ACETATE","strength":"2MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/25\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-10-25
        )

)