ANDA 090787

APOTEX INC

FDA Drug Application

Application #090787

Application Sponsors

ANDA 090787

APOTEX INC

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

	ORIG	1	AP	2011-09-29
LABELING; Labeling	SUPPL	2	AP	2013-07-31	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-05-06	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-06-02	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-06-02	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90787
            [companyName] => APOTEX INC
            [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":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)