ANDA 091397

BAXTER HLTHCARE CORP

FDA Drug Application

Application #091397

Application Sponsors

ANDA 091397

BAXTER HLTHCARE CORP

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	2013-08-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-10-20
LABELING; Labeling	SUPPL	5	AP	2014-09-23	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-10-15	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-10-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-05-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-05-06	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	0
SUPPL	5	Null	15
SUPPL	9	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91397
            [companyName] => BAXTER HLTHCARE CORP
            [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":"No"},{"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":"No"},{"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":"No"}]
            [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
        )

)