BLA 761082

KASHIV BIOSCIENCES LLC

FDA Drug Application

Application #761082

Documents

• Label: 2022-02-28
• Letter: 2022-02-28
• Letter: 2022-04-06
• Review: 2022-04-11
• Letter: 2022-10-31
• Label: 2022-11-01

Application Sponsors

BLA 761082

KASHIV BIOSCIENCES LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	300MCG/ML	0	RELEUKO	FILGRASTIM-AYOW
002	SOLUTION;SUBCUTANEOUS	480MCG/0.8 ML/VIAL	0	RELEUKO	FILGRASTIM-AYOW
003	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	300MCG/ML	0	RELEUKO	FILGRASTIM-AYOW
004	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	480MCG/1.6ML	0	RELEUKO	FILGRASTIM-AYOW

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2022-02-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7

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
        )

)