STERISCIENCE FDA Approval ANDA 216154

ANDA 216154

STERISCIENCE

FDA Drug Application

Application #216154

Application Sponsors

ANDA 216154STERISCIENCE

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION500MG/VIAL0MEROPENEMMEROPENEM
002INJECTABLE;INJECTION1GM/VIAL0MEROPENEMMEROPENEM

FDA Submissions

UNKNOWN; ORIG1AP2022-08-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

STERISCIENCE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216154
            [companyName] => STERISCIENCE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-18
        )

)

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