HOSPIRA INC FDA Approval NDA 210282

NDA 210282

HOSPIRA INC

FDA Drug Application

Application #210282

Documents

Letter2021-06-23
Label2021-06-24

Application Sponsors

NDA 210282HOSPIRA INC

Marketing Status

Prescription001
Prescription002

Application Products

001POWDER;INTRAVENOUS, SUBCUTANEOUS350MG/VIAL2DAPTOMYCINDAPTOMYCIN
002POWDER;INTRAVENOUS, SUBCUTANEOUS500MG/VIAL2DAPTOMYCINDAPTOMYCIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-06-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionTBD
002PrescriptionTBD

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210282
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/21\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210282s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/21\/2021","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\\\/2021\\\/210282s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/210282Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-21
        )

)

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