ANDA 209204

TARO

FDA Drug Application

Application #209204

Application Sponsors

ANDA 209204

TARO

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

100MG/5ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-04-30	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209204
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/30\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/22\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-04-30
        )

)