ANDA 201422

AKORN INC

FDA Drug Application

Application #201422

Application Sponsors

ANDA 201422

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

300MG/5ML

0

TOBRAMYCIN

TOBRAMYCIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-05-28
LABELING; Labeling	SUPPL	3	AP	2020-01-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-01-21	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AN

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201422
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"300MG\/5ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/21\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/21\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-21
        )

)