HETERO LABS LTD III FDA Approval ANDA 216356

ANDA 216356

HETERO LABS LTD III

FDA Drug Application

Application #216356

Application Sponsors

ANDA 216356HETERO LABS LTD III

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL250MG0TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216356
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIENTINE HYDROCHLORIDE","activeIngredients":"TRIENTINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIENTINE HYDROCHLORIDE","submission":"TRIENTINE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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