ANDA 202850

ANI PHARMS INC

FDA Drug Application

Application #202850

Application Sponsors

ANDA 202850

ANI PHARMS INC

Marketing Status

• Over-the-counter: 001

Application Products

001

FOR SOLUTION;ORAL

17GM/SCOOPFUL

0

POLYETHYLENE GLYCOL 3350

POLYETHYLENE GLYCOL 3350

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-12-15
LABELING; Labeling	SUPPL	2	AP	2021-11-30	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	15

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202850
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POLYETHYLENE GLYCOL 3350","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/SCOOPFUL","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/15\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-15
        )

)