ALVOGEN PINE BROOK FDA Approval ANDA 208269

ANDA 208269

ALVOGEN PINE BROOK

FDA Drug Application

Application #208269

Documents

Letter2021-04-13

Application Sponsors

ANDA 208269ALVOGEN PINE BROOK

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET, EXTENDED RELEASE;ORAL20MG0HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
002TABLET, EXTENDED RELEASE;ORAL30MG0HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
003TABLET, EXTENDED RELEASE;ORAL40MG0HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
004TABLET, EXTENDED RELEASE;ORAL60MG0HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
005TABLET, EXTENDED RELEASE;ORAL80MG0HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
006TABLET, EXTENDED RELEASE;ORAL100MG0HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE
007TABLET, EXTENDED RELEASE;ORAL120MG0HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB
007PrescriptionAB

CDER Filings

ALVOGEN PINE BROOK
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208269
            [companyName] => ALVOGEN PINE BROOK
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"80MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-01
        )

)

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