ANDA 090343

INFORLIFE

FDA Drug Application

Application #090343

Application Sponsors

ANDA 090343

INFORLIFE

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 250MG/50ML (EQ 5MG/ML)	0	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN
002	INJECTABLE;INJECTION	EQ 500MG/100ML (EQ 5MG/ML)	0	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN
003	INJECTABLE;INJECTION	EQ 750MG/150ML (EQ 5MG/ML)	0	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN

FDA Submissions

	ORIG	1	AP	2011-07-07
LABELING; Labeling	SUPPL	4	AP	2012-02-10
REMS; REMS	SUPPL	6	AP	2012-03-29
LABELING; Labeling	SUPPL	12	AP	2012-11-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-11-08	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-11-08	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-04-17	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-04-17	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	27	AP	2019-05-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	7
SUPPL	22	Null	15
SUPPL	24	Null	15
SUPPL	26	Null	7
SUPPL	27	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

INFORLIFE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90343
            [companyName] => INFORLIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 250MG\/50ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/100ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 750MG\/150ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LEVOFLOXACIN","actionType":"EQ 250MG\/50ML (EQ 5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LEVOFLOXACIN","actionType":"EQ 500MG\/100ML (EQ 5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"LEVOFLOXACIN","actionType":"EQ 750MG\/150ML (EQ 5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)