NDA 216774

TEVA PHARMS

FDA Drug Application

Application #216774

Documents

• Letter: 2022-10-04

Application Sponsors

NDA 216774

TEVA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET; ORAL	9MG	0	ALVAIZ	ELTROMBOPAG
002	TABLET; ORAL	18MG	0	ALVAIZ	ELTROMBOPAG
003	TABLET; ORAL	36MG	0	ALVAIZ	ELTROMBOPAG
004	TABLET;ORAL	54MG	0	ALVAIZ	ELTROMBOPAG

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

TA

2022-10-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216774
            [companyName] => TEVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"9MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"18MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"36MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALVAIZ","activeIngredients":"ELTROMBOPAG","strength":"54MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216774Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-03
        )

)