ALVOGEN FDA Approval ANDA 215002

ANDA 215002

ALVOGEN

FDA Drug Application

Application #215002

Application Sponsors

ANDA 215002ALVOGEN

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL75MG;25MG0NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ALVOGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215002
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN (MONOHYDRATE\/MACROCRYSTALS)","activeIngredients":"NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE","strength":"75MG;25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-20
        )

)

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