ALEMBIC PHARMS LTD FDA Approval ANDA 206741

ANDA 206741

ALEMBIC PHARMS LTD

FDA Drug Application

Application #206741

Application Sponsors

ANDA 206741ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG0ITRACONAZOLEITRACONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2016-12-13STANDARD
LABELING; LabelingSUPPL2AP2019-10-04STANDARD
LABELING; LabelingSUPPL3AP2019-10-04STANDARD
LABELING; LabelingSUPPL4AP2019-10-04STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7
SUPPL4Null7

TE Codes

001PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206741
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ITRACONAZOLE","activeIngredients":"ITRACONAZOLE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/04\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-04
        )

)

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