GLAND PHARMA LTD FDA Approval ANDA 214645

ANDA 214645

GLAND PHARMA LTD

FDA Drug Application

Application #214645

Application Sponsors

ANDA 214645GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001SOLUTION, GEL FORMING/DROPS;OPHTHALMICEQ 0.25% BASE0TIMOLOL MALEATETIMOLOL MALEATE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-24STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214645
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION, GEL FORMING\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TIMOLOL MALEATE","submission":"TIMOLOL MALEATE","actionType":"EQ 0.25% BASE","submissionClassification":"SOLUTION, GEL FORMING\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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