TEVA PHARMS INC FDA Approval ANDA 216961

ANDA 216961

TEVA PHARMS INC

FDA Drug Application

Application #216961

Application Sponsors

ANDA 216961TEVA PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL300MG0THEOPHYLLINETHEOPHYLLINE
002TABLET, EXTENDED RELEASE;ORAL450MG0THEOPHYLLINETHEOPHYLLINE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TEVA PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216961
            [companyName] => TEVA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE","activeIngredients":"THEOPHYLLINE","strength":"450MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/12\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-12
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.