AUROLIFE PHARMA LLC FDA Approval ANDA 205814

ANDA 205814

AUROLIFE PHARMA LLC

FDA Drug Application

Application #205814

Application Sponsors

ANDA 205814AUROLIFE PHARMA LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2MG0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
002TABLET;ORAL4MG0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
003TABLET;ORAL8MG0HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2016-05-13STANDARD
REMS; REMSSUPPL2AP2018-09-18
LABELING; LabelingSUPPL3AP2020-04-07STANDARD
LABELING; LabelingSUPPL4AP2020-04-07STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null7
SUPPL4Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AUROLIFE PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205814
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/07\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-07
        )

)

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