BLA 761111

HOSPIRA INC

FDA Drug Application

Application #761111

Documents

• Label: 2020-06-11
• Letter: 2020-06-12
• Review: 2020-08-11
• Label: 2021-04-19
• Letter: 2021-04-19

Application Sponsors

BLA 761111

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

6MG/0.6ML

0

NYVEPRIA

PEGFILGRASTIM-APGF

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2020-06-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-04-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761111
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYVEPRIA","activeIngredients":"PEGFILGRASTIM-APGF","strength":"6MG\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761111lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761111lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761111Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-10
        )

)