ANDA 203991

LUPIN LTD

FDA Drug Application

Application #203991

Application Sponsors

ANDA 203991

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.03%

0

BIMATOPROST

BIMATOPROST

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-02-20
LABELING; Labeling	SUPPL	6	AP	2022-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2020-11-24	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-11-02	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	11	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AT

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203991
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-02-20
        )

)