LAURUS FDA Approval ANDA 216332

ANDA 216332

LAURUS

FDA Drug Application

Application #216332

Application Sponsors

ANDA 216332LAURUS

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 600MG BASE;300MG0ABACAVIR SULFATE AND LAMIVUDINEABACAVIR SULFATE; LAMIVUDINE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

LAURUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216332
            [companyName] => LAURUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE AND LAMIVUDINE","activeIngredients":"ABACAVIR SULFATE; LAMIVUDINE","strength":"EQ 600MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-25
        )

)

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