BLA 761080

HOSPIRA INC

FDA Drug Application

Application #761080

Documents

• Label: 2018-07-20
• Letter: 2018-07-23
• Review: 2019-02-21
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2021-05-04
• Label: 2021-05-07

Application Sponsors

BLA 761080

HOSPIRA INC

Marketing Status

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

Application Products

001	VIAL;SINGLE-DOSE	300MCG/ML	0	NIVESTYM	FILGRASTIM-AAFI
002	VIAL;SINGLE-DOSE	480MCG/1.6ML	0	NIVESTYM	FILGRASTIM-AAFI
003	INJECTABLE;INJECTION	300MCG/0.5ML	0	NIVESTYM	FILGRASTIM-AAFI
004	INJECTABLE;INJECTION	480MCG/0.8ML	0	NIVESTYM	FILGRASTIM-AAFI

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2018-07-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-05-03	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	7	Null	15

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761080
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIVESTYM","activeIngredients":"FILGRASTIM-AAFI","strength":"300MCG\/ML","dosageForm":"VIAL;SINGLE-DOSE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NIVESTYM","activeIngredients":"FILGRASTIM-AAFI","strength":"480MCG\/1.6ML","dosageForm":"VIAL;SINGLE-DOSE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NIVESTYM","activeIngredients":"FILGRASTIM-AAFI","strength":"300MCG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NIVESTYM","activeIngredients":"FILGRASTIM-AAFI","strength":"480MCG\/0.8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/20\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761080s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761080s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761080Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761080Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-07-20
        )

)