ANDA 078062

BAXTER HLTHCARE CORP

FDA Drug Application

Application #078062

Application Sponsors

ANDA 078062

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	200MG/20ML (10MG/ML)	0	CIPROFLOXACIN	CIPROFLOXACIN
002	INJECTABLE;INJECTION	400MG/40ML (10MG/ML)	0	CIPROFLOXACIN	CIPROFLOXACIN

FDA Submissions

	ORIG	1	AP	2008-04-29
LABELING; Labeling	SUPPL	2	AP	2009-05-26
LABELING; Labeling	SUPPL	3	AP	2010-01-29
LABELING; Labeling	SUPPL	6	AP	2011-05-16
LABELING; Labeling	SUPPL	7	AP	2012-05-24
LABELING; Labeling	SUPPL	8	AP	2012-09-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-06-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-06-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-06-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-01-27	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-01-27	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-10-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-05-06	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-05-06	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78062
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN","activeIngredients":"CIPROFLOXACIN","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"CIPROFLOXACIN","activeIngredients":"CIPROFLOXACIN","strength":"400MG\/40ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN","submission":"CIPROFLOXACIN","actionType":"200MG\/20ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN","submission":"CIPROFLOXACIN","actionType":"400MG\/40ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)