HETERO LABS LTD III FDA Approval ANDA 215776

ANDA 215776

HETERO LABS LTD III

FDA Drug Application

Application #215776

Application Sponsors

ANDA 215776HETERO LABS LTD III

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL25MG/ML0NAPROXENNAPROXEN

FDA Submissions

UNKNOWN; ORIG1AP2022-06-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215776
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"25MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-07
        )

)

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