AKORN FDA Approval ANDA 078261

ANDA 078261

AKORN

FDA Drug Application

Application #078261

Application Sponsors

ANDA 078261AKORN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10MG/ML0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE

FDA Submissions

ORIG1AP2010-04-14
LABELING; LabelingSUPPL2AP2015-02-04STANDARD
LABELING; LabelingSUPPL4AP2020-05-20STANDARD
LABELING; LabelingSUPPL7AP2020-05-20STANDARD

Submissions Property Types

ORIG1Null42
SUPPL2Null15
SUPPL4Null15
SUPPL7Null7

TE Codes

001PrescriptionAP

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78261
            [companyName] => AKORN
            [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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.