KASHIV BIOSCIENCES LLC FDA Approval BLA 761082

BLA 761082

KASHIV BIOSCIENCES LLC

FDA Drug Application

Application #761082

Documents

Label2022-02-28
Letter2022-02-28
Letter2022-04-06
Review2022-04-11

Application Sponsors

BLA 761082KASHIV BIOSCIENCES LLC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INJECTION300MCG/ML0RELEUKOFILGRASTIM-AYOW
002SOLUTION;SUBCUTANEOUS480MCG/0.8 ML/VIAL0RELEUKOFILGRASTIM-AYOW
003SOLUTION;INTRAVENOUS, SUBCUTANEOUS300MCG/ML0RELEUKOFILGRASTIM-AYOW
004SOLUTION;INTRAVENOUS, SUBCUTANEOUS480MCG/1.6ML0RELEUKOFILGRASTIM-AYOW

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-02-25STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

KASHIV BIOSCIENCES LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761082
            [companyName] => KASHIV BIOSCIENCES LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RELEUKO","activeIngredients":"FILGRASTIM-AYOW","strength":"300MCG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/25\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761082s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761082s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761082Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-02-25
        )

)

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