NDA 215596

TAKEDA PHARMS USA

FDA Drug Application

Application #215596

Documents

• Letter: 2021-11-24
• Label: 2021-11-24
• Review: 2021-12-22
• Letter: 2022-01-19
• Letter: 2022-09-09
• Label: 2022-09-10

Application Sponsors

NDA 215596

TAKEDA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

400MG

0

LIVTENCITY

MARIBAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-11-23	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2022-09-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Orphan	5

TE Codes

001

Prescription

TBD

CDER Filings

TAKEDA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215596
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIVTENCITY","activeIngredients":"MARIBAVIR","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215596lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215596lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215596Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-23
        )

)