ACTAVIS INC FDA Approval ANDA 204549

ANDA 204549

ACTAVIS INC

FDA Drug Application

Application #204549

Application Sponsors

ANDA 204549ACTAVIS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTION200MG/5.26ML (38MG/ML)0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
002INJECTABLE;INJECTION1GM/26.3ML (38MG/ML)0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
003INJECTABLE;INJECTION2GM/52.6ML (38MG/ML)0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2016-04-11STANDARD
LABELING; LabelingSUPPL2AP2019-05-03STANDARD
LABELING; LabelingSUPPL3AP2020-06-23STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null15

CDER Filings

ACTAVIS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204549
            [companyName] => ACTAVIS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"200MG\/5.26ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"1GM\/26.3ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"2GM\/52.6ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/23\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-23
        )

)

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