ANDA 091375

HIKMA FARMACEUTICA

FDA Drug Application

Application #091375

Application Sponsors

ANDA 091375

HIKMA FARMACEUTICA

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

N/A; Not Applicable	ORIG	1	AP	2011-09-16
REMS; REMS	SUPPL	2	AP	2012-07-25
LABELING; Labeling	SUPPL	4	AP	2013-11-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-04-15	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-04-15	STANDARD
LABELING; Labeling	SUPPL	14	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-05-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	9	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91375
            [companyName] => HIKMA FARMACEUTICA
            [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
        )

)