MICRO LABS FDA Approval ANDA 215936

ANDA 215936

MICRO LABS

FDA Drug Application

Application #215936

Application Sponsors

ANDA 215936MICRO LABS

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 2% BASE;EQ 0.5% BASE0DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

FDA Submissions

UNKNOWN; ORIG1AP2022-01-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215936
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","strength":"EQ 2% BASE;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-25
        )

)

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