NDA 209191

HOSPIRA INC

FDA Drug Application

Application #209191

Documents

• Letter: 2017-04-27
• Label: 2018-07-13
• Letter: 2018-07-12
• Review: 2018-11-13
• Letter: 2021-12-21
• Label: 2022-05-04
• Review: 2022-12-07
• Label: 2022-12-12
• Letter: 2022-12-12

Application Sponsors

NDA 209191

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	POWDER;INTRAVENOUS, SUBCUTANEOUS	2.5MG/VIAL	1	BORTEZOMIB	BORTEZOMIB
002	POWDER;INTRAVENOUS, SUBCUTANEOUS	1MG/VIAL	1	BORTEZOMIB	BORTEZOMIB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-07-12	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2022-12-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	6

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209191
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"2.5MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"1MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/12\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209191lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209191lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209191Orig1s000Ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209191Orig1s000TAltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209191Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-07-12
        )

)