ALEMBIC PHARMS LTD FDA Approval ANDA 212942

ANDA 212942

ALEMBIC PHARMS LTD

FDA Drug Application

Application #212942

Application Sponsors

ANDA 212942ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-10-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212942
            [companyName] => ALEMBIC PHARMS 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"},{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION, GEL FORMING\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-22
        )

)

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