SUN PHARM FDA Approval ANDA 211980

ANDA 211980

SUN PHARM

FDA Drug Application

Application #211980

Application Sponsors

ANDA 211980SUN PHARM

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML0NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211980
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOREPINEPHRINE BITARTRATE","activeIngredients":"NOREPINEPHRINE BITARTRATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NOREPINEPHRINE BITARTRATE","submission":"NOREPINEPHRINE BITARTRATE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.