ANDA 205647

HI TECH

FDA Drug Application

Application #205647

Application Sponsors

ANDA 205647

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

100MG/5ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-11-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205647
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/22\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-22
        )

)