IDENTIRX PHARMS FDA Approval ANDA 212592

ANDA 212592

IDENTIRX PHARMS

FDA Drug Application

Application #212592

Documents

Letter2022-01-12

Application Sponsors

ANDA 212592IDENTIRX PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.25% BASE0TIMOLOL MALEATETIMOLOL MALEATE
002SOLUTION/DROPS;OPHTHALMICEQ 0.5% BASE0TIMOLOL MALEATETIMOLOL MALEATE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT3
002PrescriptionAT3

CDER Filings

IDENTIRX PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212592
            [companyName] => IDENTIRX PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-13
        )

)

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