ANDA 091644

AKORN

FDA Drug Application

Application #091644

Application Sponsors

ANDA 091644

AKORN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG/20ML (EQ 25MG/ML)	0	LEVOFLOXACIN	LEVOFLOXACIN
002	INJECTABLE;INJECTION	EQ 750MG/30ML (EQ 25MG/ML)	0	LEVOFLOXACIN	LEVOFLOXACIN

FDA Submissions

	ORIG	1	AP	2011-06-20
LABELING; Labeling	SUPPL	2	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-05-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-05-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	31
SUPPL	6	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91644
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/20ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 750MG\/30ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"EQ 500MG\/20ML (EQ 25MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"EQ 750MG\/30ML (EQ 25MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)