ACTAVIS LABS FL FDA Approval ANDA 205063

ANDA 205063

ACTAVIS LABS FL

FDA Drug Application

Application #205063

Application Sponsors

ANDA 205063ACTAVIS LABS FL

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001CAPSULE;ORAL10MG0ISOTRETINOINISOTRETINOIN
002CAPSULE;ORAL20MG0ISOTRETINOINISOTRETINOIN
003CAPSULE;ORAL25MG0ISOTRETINOINISOTRETINOIN
004CAPSULE;ORAL30MG0ISOTRETINOINISOTRETINOIN
005CAPSULE;ORAL35MG0ISOTRETINOINISOTRETINOIN
006CAPSULE;ORAL40MG0ISOTRETINOINISOTRETINOIN

FDA Submissions

UNKNOWN; ORIG1AP2021-03-31STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB2
002PrescriptionAB2
003PrescriptionAB2
004PrescriptionAB2
005PrescriptionAB2
006PrescriptionAB2

CDER Filings

ACTAVIS LABS FL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205063
            [companyName] => ACTAVIS LABS FL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"35MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/31\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-31
        )

)

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