ANDA 201006

BAUSCH AND LOMB

FDA Drug Application

Application #201006

Application Sponsors

ANDA 201006

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.005%

0

LATANOPROST

LATANOPROST

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2011-03-22
LABELING; Labeling	SUPPL	4	AP	2013-02-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-12-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-09-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201006
            [companyName] => BAUSCH AND LOMB
            [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":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/09\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/27\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-21
        )

)