HOSPIRA INC FDA Approval ANDA 078591

ANDA 078591

HOSPIRA INC

FDA Drug Application

Application #078591

Application Sponsors

ANDA 078591HOSPIRA INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10MG/ML0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE

FDA Submissions

ORIG1AP2008-06-17
LABELING; LabelingSUPPL2AP2015-02-18STANDARD
LABELING; LabelingSUPPL5AP2020-08-18STANDARD
LABELING; LabelingSUPPL12AP2020-08-18STANDARD

Submissions Property Types

SUPPL1Null15
SUPPL2Null7
SUPPL5Null15
SUPPL12Null7

TE Codes

001PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78591
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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