NDA 209359

HOSPIRA INC

FDA Drug Application

Application #209359

Documents

• Letter: 2019-11-07
• Label: 2020-04-30
• Review: 2020-06-30
• Letter: 2022-01-28
• Letter: 2022-10-28
• Label: 2022-10-31

Application Sponsors

NDA 209359

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

1MG/10ML (0.1MG/ML)

1

EPINEPHRINE (COPACKAGED)

EPINEPHRINE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA	ORIG	1	AP	2019-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2022-09-29	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2022-01-25	N/A

Submissions Property Types

ORIG

1

Null

7

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209359
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINEPHRINE (COPACKAGED)","activeIngredients":"EPINEPHRINE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/05\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209359s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/05\/2019","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\\\/label\\\/2019\\\/209359s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209359Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209359Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-11-05
        )

)