ANDA 203051

HI TECH

FDA Drug Application

Application #203051

Application Sponsors

ANDA 203051

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;TOPICAL

0.03%

0

BIMATOPROST

BIMATOPROST

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-09
LABELING; Labeling	SUPPL	3	AP	2022-11-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-11-23	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203051
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-09
        )

)