ANDA 090679

MACLEODS PHARMS LTD

FDA Drug Application

Application #090679

Application Sponsors

ANDA 090679

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG;300MG

0

LAMIVUDINE AND ZIDOVUDINE

LAMIVUDINE; ZIDOVUDINE

FDA Submissions

	ORIG	1	AP	2018-08-29
LABELING; Labeling	SUPPL	16	AP	2019-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	16	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90679
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE AND ZIDOVUDINE","activeIngredients":"LAMIVUDINE; ZIDOVUDINE","strength":"150MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE AND ZIDOVUDINE","submission":"LAMIVUDINE; ZIDOVUDINE","actionType":"150MG;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)