ANDA 209797

GLAND PHARMA LTD

FDA Drug Application

Application #209797

Application Sponsors

ANDA 209797

GLAND PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.01%

0

BIMATOPROST

BIMATOPROST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-10-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209797
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.01%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-29
        )

)