BLA 761084

KASHIV BIOSCIENCES LLC

FDA Drug Application

Application #761084

Documents

• Label: 2022-05-26
• Letter: 2022-06-07
• Review: 2022-07-15

Application Sponsors

BLA 761084

KASHIV BIOSCIENCES LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

6MG/0.6ML

0

FYLNETRA

PEGFILGRASTIM-PBBK

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2022-05-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

KASHIV BIOSCIENCES LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761084
            [companyName] => KASHIV BIOSCIENCES LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FYLNETRA","activeIngredients":"PEGFILGRASTIM-PBBK","strength":"6MG\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761084s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761084s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-05-26
        )

)