ALEMBIC PHARMS LTD FDA Approval ANDA 211792

ANDA 211792

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211792

Application Sponsors

ANDA 211792ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 500MG BASE0AZITHROMYCINAZITHROMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2020-01-28STANDARD
LABELING; LabelingSUPPL9AP2022-01-13STANDARD

Submissions Property Types

ORIG1Null7
SUPPL9Null7

TE Codes

001PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211792
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/04\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-04
        )

)

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