TWI PHARMS FDA Approval ANDA 202666

ANDA 202666

TWI PHARMS

FDA Drug Application

Application #202666

Application Sponsors

ANDA 202666TWI PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED RELEASE;ORAL30MG0DEXLANSOPRAZOLEDEXLANSOPRAZOLE
002CAPSULE, DELAYED RELEASE;ORAL60MG0DEXLANSOPRAZOLEDEXLANSOPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-16

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TWI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202666
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXLANSOPRAZOLE","activeIngredients":"DEXLANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXLANSOPRAZOLE","activeIngredients":"DEXLANSOPRAZOLE","strength":"60MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-16
        )

)

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