HOSPIRA INC FDA Approval BLA 761080

BLA 761080

HOSPIRA INC

FDA Drug Application

Application #761080

Documents

Label2018-07-20
Letter2018-07-23
Review2019-02-21
Pediatric CDTL Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2021-05-04
Label2021-05-07

Application Sponsors

BLA 761080HOSPIRA INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001VIAL;SINGLE-DOSE300MCG/ML0NIVESTYMFILGRASTIM-AAFI
002VIAL;SINGLE-DOSE480MCG/1.6ML0NIVESTYMFILGRASTIM-AAFI
003INJECTABLE;INJECTION300MCG/0.5ML0NIVESTYMFILGRASTIM-AAFI
004INJECTABLE;INJECTION480MCG/0.8ML0NIVESTYMFILGRASTIM-AAFI

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2018-07-20STANDARD
LABELING; LabelingSUPPL7AP2021-05-03STANDARD

Submissions Property Types

ORIG1Null40
SUPPL7Null15

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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.