DR REDDYS LABS LTD FDA Approval ANDA 202077

ANDA 202077

DR REDDYS LABS LTD

FDA Drug Application

Application #202077

Application Sponsors

ANDA 202077DR REDDYS LABS LTD

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.005%0LATANOPROSTLATANOPROST

FDA Submissions

N/A; Not ApplicableORIG1AP2013-02-11
SUPPL11AP2013-02-11

Submissions Property Types

ORIG1Null19
SUPPL11Null0

TE Codes

001PrescriptionAT

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202077
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LATANOPROST","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/11\/2013","submission":"SUPPL-11","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-17
        )

)

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