ANDA 200925

AMRING PHARMS

FDA Drug Application

Application #200925

Application Sponsors

ANDA 200925

AMRING PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.005%

0

LATANOPROST

LATANOPROST

FDA Submissions

	ORIG	1	AP	2011-03-22
LABELING; Labeling	SUPPL	4	AP	2020-06-12	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-06-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-08-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AT

CDER Filings

AMRING PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200925
            [companyName] => AMRING PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LATANOPROST","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/12\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/12\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-12
        )

)