BLA 761112

ABLYNX NV

FDA Drug Application

Application #761112

Documents

• Label: 2019-02-06
• Letter: 2019-02-13
• Review: 2019-03-15
• Letter: 2020-12-21
• Label: 2020-12-22
• Label: 2022-02-25

Application Sponsors

BLA 761112

ABLYNX NV

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

11MG/VIAL

0

CABLIVI

CAPLACIZUMAB-YHDP

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-02-06	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2020-12-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-02-23	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	7	Null	15
SUPPL	9	Null	7

CDER Filings

ABLYNX NV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761112
            [companyName] => ABLYNX NV
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABLIVI","activeIngredients":"CAPLACIZUMAB-YHDP","strength":"11MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/06\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761112Orig1s000ltr.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761112Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761112Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761112Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-02-06
        )

)