BLA 761268

CELLTRION

FDA Drug Application

Application #761268

Documents

• Label: 2022-09-28
• Letter: 2022-09-29
• Review: 2022-12-13

Application Sponsors

BLA 761268

CELLTRION

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	100MG/4ML(25MG/ML)	0	VEGZELMA	BEVACIZUMAB-ADCD
002	INJECTABLE;INJECTION	400MG/16ML(25MG/ML)	0	VEGZELMA	BEVACIZUMAB-ADCD

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761268
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"VEGZELMA","activeIngredients":"BEVACIZUMAB-ADCD","strength":"100MG\/4ML(25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/27\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761268s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761268s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761268Orig1s000Correctedltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-27
        )

)