ANDA 202442

FDC LTD

FDA Drug Application

Application #202442

Application Sponsors

ANDA 202442

FDC LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.005%

0

LATANOPROST

LATANOPROST

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-04-22
LABELING; Labeling	SUPPL	2	AP	2020-02-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-02-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-02-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-11-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	9	Null	7

TE Codes

001

Prescription

AT

CDER Filings

FDC LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202442
            [companyName] => FDC LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LATANOPROST","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/19\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/19\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/19\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-19
        )

)