NDA 203797

HOSPIRA INC

FDA Drug Application

Application #203797

Documents

• Letter: 2013-03-19
• Letter: 2015-02-19

Application Sponsors

NDA 203797

HOSPIRA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

POWDER;INTRAVENOUS

350MG/VIAL

0

DAPTOMYCIN

DAPTOMYCIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2013-03-15

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203797
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203797Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203797Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-03-15
        )

)