ANDA 200839

MACLEODS PHARMS LTD

FDA Drug Application

Application #200839

Application Sponsors

ANDA 200839

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	250MG	0	LEVOFLOXACIN	LEVOFLOXACIN
002	TABLET;ORAL	500MG	0	LEVOFLOXACIN	LEVOFLOXACIN
003	TABLET;ORAL	750MG	0	LEVOFLOXACIN	LEVOFLOXACIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-03-22
LABELING; Labeling	SUPPL	4	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	21	AP	2021-01-21	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-01-21	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-01-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	21	Null	7
SUPPL	23	Null	7
SUPPL	26	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200839
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/03\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/06\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/06\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/06\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-03
        )

)