BLA 761231

AMNEAL PHARMS LLC

FDA Drug Application

Application #761231

Documents

• Label: 2022-04-13
• Letter: 2022-04-15
• Review: 2022-05-11

Application Sponsors

BLA 761231

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	100MG/4ML(25MG/ML	0	ALYMSYS	BEVACIZUMAB-MALY
002	INJECTABLE;INJECTION	400MG/16ML(25MG/ML	0	ALYMSYS	BEVACIZUMAB-MALY

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-04-13

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

AMNEAL PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761231
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALYMSYS","activeIngredients":"BEVACIZUMAB-MALY","strength":"100MG\/4ML(25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ALYMSYS","activeIngredients":"BEVACIZUMAB-MALY","strength":"400MG\/16ML(25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/13\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761231s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761231s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761231Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-04-13
        )

)