ANDA 210149

GUARDIAN DRUG

FDA Drug Application

Application #210149

Application Sponsors

ANDA 210149

GUARDIAN DRUG

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

100MG/5ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2022-05-10	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7

CDER Filings

GUARDIAN DRUG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210149
            [companyName] => GUARDIAN DRUG
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-15
        )

)