BIONPHARMA INC FDA Approval ANDA 210000

ANDA 210000

BIONPHARMA INC

FDA Drug Application

Application #210000

Application Sponsors

ANDA 210000BIONPHARMA INC

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 250MG BASE0AZITHROMYCINAZITHROMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2019-02-26STANDARD
LABELING; LabelingSUPPL3AP2019-07-05STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15

TE Codes

001PrescriptionAB

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210000
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/05\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-05
        )

)

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