WATSON LABS TEVA FDA Approval ANDA 201949

ANDA 201949

WATSON LABS TEVA

FDA Drug Application

Application #201949

Application Sponsors

ANDA 201949WATSON LABS TEVA

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.2%;EQ 0.5% BASE0BRIMONIDINE TARTRATE AND TIMOLOL MALEATEBRIMONIDINE TARTRATE; TIMOLOL MALEATE

FDA Submissions

N/A; Not ApplicableORIG1AP2022-10-04

Submissions Property Types

ORIG1Null17

TE Codes

001PrescriptionAB

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201949
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIMONIDINE TARTRATE AND TIMOLOL MALEATE","activeIngredients":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","strength":"0.2%;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-04
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.