ANDA 214489

LUPIN PHARMS

FDA Drug Application

Application #214489

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 214489

LUPIN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET; ORAL	40MG	0	AZILSARTAN MEDOXOMIL	AZILSARTAN MEDOXOMIL
002	TABLET; ORAL	80MG	0	AZILSARTAN MEDOXOMIL	AZILSARTAN MEDOXOMIL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214489
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZILSARTAN MEDOXOMIL","activeIngredients":"AZILSARTAN MEDOXOMIL","strength":"40MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"AZILSARTAN MEDOXOMIL","activeIngredients":"AZILSARTAN MEDOXOMIL","strength":"80MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214489Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-22
        )

)