ALEMBIC PHARMS LTD FDA Approval ANDA 213099

ANDA 213099

ALEMBIC PHARMS LTD

FDA Drug Application

Application #213099

Application Sponsors

ANDA 213099ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2021-05-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213099
            [companyName] => ALEMBIC PHARMS LTD
            [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":"05\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-04
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.