ZYDUS PHARMS FDA Approval ANDA 216441

ANDA 216441

ZYDUS PHARMS

FDA Drug Application

Application #216441

Application Sponsors

ANDA 216441ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL20MG0FAMOTIDINEFAMOTIDINE
002TABLET;ORAL40MG0FAMOTIDINEFAMOTIDINE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216441
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-03
        )

)

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