ANDA 203173

AKORN INC

FDA Drug Application

Application #203173

Application Sponsors

ANDA 203173

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

6GM/30ML (200MG/ML)

0

ACETYLCYSTEINE

ACETYLCYSTEINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-03-24
LABELING; Labeling	SUPPL	2	AP	2019-08-19	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203173
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"6GM\/30ML (200MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/19\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-19
        )

)