GLAND PHARMA LTD FDA Approval ANDA 212628

ANDA 212628

GLAND PHARMA LTD

FDA Drug Application

Application #212628

Application Sponsors

ANDA 212628GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.3%0TOBRAMYCINTOBRAMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2020-05-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212628
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-09
        )

)

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