MICRO LABS FDA Approval ANDA 204777

ANDA 204777

MICRO LABS

FDA Drug Application

Application #204777

Application Sponsors

ANDA 204777MICRO LABS

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 2.0% BASE;EQ 0.5% BASE0DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-28

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204777
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","strength":"EQ 2.0% BASE;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-28
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.