MACLEODS PHARMS LTD FDA Approval ANDA 090198

ANDA 090198

MACLEODS PHARMS LTD

FDA Drug Application

Application #090198

Documents

Letter2008-10-09

Application Sponsors

ANDA 090198MACLEODS PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL150MG0LAMIVUDINELAMIVUDINE
002TABLET;ORAL300MG0LAMIVUDINELAMIVUDINE

FDA Submissions

ORIG1AP2019-05-01
LABELING; LabelingSUPPL14AP2020-06-11STANDARD

Submissions Property Types

ORIG1Null15
SUPPL14Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90198
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE","submission":"LAMIVUDINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMIVUDINE","submission":"LAMIVUDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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