ANDA 202666

TWI PHARMS

FDA Drug Application

Application #202666

Application Sponsors

ANDA 202666

TWI PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, DELAYED RELEASE;ORAL	30MG	0	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE
002	CAPSULE, DELAYED RELEASE;ORAL	60MG	0	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-16

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)