ANDA 091436

BAXTER HLTHCARE CORP

FDA Drug Application

Application #091436

Application Sponsors

ANDA 091436

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG/20ML (EQ 25MG/ML)

0

LEVOFLOXACIN

LEVOFLOXACIN

FDA Submissions

	ORIG	1	AP	2013-06-05
LABELING; Labeling	SUPPL	3	AP	2014-09-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-10-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2018-10-15	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-05-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-05-06	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91436
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/20ML (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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)