AUROBINDO PHARMA LTD FDA Approval ANDA 209236

ANDA 209236

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209236

Application Sponsors

ANDA 209236AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0NIACINNIACIN
002TABLET, EXTENDED RELEASE;ORAL750MG0NIACINNIACIN
003TABLET, EXTENDED RELEASE;ORAL1GM0NIACINNIACIN

FDA Submissions

UNKNOWN; ORIG1AP2018-02-01STANDARD
LABELING; LabelingSUPPL3AP2022-11-29STANDARD
LABELING; LabelingSUPPL5AP2022-11-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL5Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209236
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-01
        )

)

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