ANDA 090198

MACLEODS PHARMS LTD

FDA Drug Application

Application #090198

Documents

• Letter: 2008-10-09

Application Sponsors

ANDA 090198

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	150MG	0	LAMIVUDINE	LAMIVUDINE
002	TABLET;ORAL	300MG	0	LAMIVUDINE	LAMIVUDINE

FDA Submissions

	ORIG	1	AP	2019-05-01
LABELING; Labeling	SUPPL	14	AP	2020-06-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	14	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)