NDA 202515

HOSPIRA INC

FDA Drug Application

Application #202515

Documents

• Label: 2011-11-14
• Letter: 2011-11-28
• Review: 2012-06-26
• Summary Review: 2012-06-26
• Label: 2016-12-20
• Letter: 2016-12-21
• Label: 2019-10-07
• Letter: 2019-10-08
• Letter: 2020-10-13
• Label: 2020-10-19
• Label: 2021-04-30
• Letter: 2021-04-30
• Letter: 2022-05-02
• Label: 2022-05-03

Application Sponsors

NDA 202515

HOSPIRA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Discontinued: 005
• Prescription: 006

Application Products

001	INJECTABLE;INJECTION	2MG/ML	1	MORPHINE SULFATE	MORPHINE SULFATE
002	INJECTABLE;INJECTION	4MG/ML	1	MORPHINE SULFATE	MORPHINE SULFATE
003	INJECTABLE;INJECTION	8MG/ML	1	MORPHINE SULFATE	MORPHINE SULFATE
004	INJECTABLE;INJECTION	10MG/ML	1	MORPHINE SULFATE	MORPHINE SULFATE
005	INJECTABLE;INJECTION	15MG/ML	1	MORPHINE SULFATE	MORPHINE SULFATE
006	INJECTABLE;INJECTION	50MG/ML	1	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA	ORIG	1	AP	2011-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2013-08-14	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2020-08-17	N/A
LABELING; Labeling	SUPPL	17	AP	2019-10-07	STANDARD
EFFICACY; Efficacy	SUPPL	25	AP	2021-04-29	STANDARD
LABELING; Labeling	SUPPL	33	AP	2021-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	0
SUPPL	6	Null	7
SUPPL	17	Null	7
SUPPL	25	Null	7
SUPPL	33	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202515
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"8MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202515s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202515s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202515s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202515Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/14\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202515Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202515s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202515_morphine_sulfate_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202515Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202515s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202515Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202515s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202515Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"08\/14\/2013","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-07
        )

)