HIKMA FDA Approval ANDA 201172

ANDA 201172

HIKMA

FDA Drug Application

Application #201172

Application Sponsors

ANDA 201172HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL250MG0TINIDAZOLETINIDAZOLE
002TABLET;ORAL500MG0TINIDAZOLETINIDAZOLE

FDA Submissions

N/A; Not ApplicableORIG1AP2012-04-30
LABELING; LabelingSUPPL2AP2020-05-26STANDARD
LABELING; LabelingSUPPL3AP2022-06-17STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201172
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TINIDAZOLE","activeIngredients":"TINIDAZOLE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TINIDAZOLE","activeIngredients":"TINIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/30\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-26
        )

)

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