ANDA 078252

INFORLIFE

FDA Drug Application

Application #078252

Documents

• Letter: 2008-03-19

Application Sponsors

ANDA 078252

INFORLIFE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	200MG/100ML	0	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN
002	INJECTABLE;INJECTION	400MG/200ML	0	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN

FDA Submissions

	ORIG	1	AP	2008-03-18
LABELING; Labeling	SUPPL	4	AP	2009-06-19
LABELING; Labeling	SUPPL	5	AP	2009-10-05
LABELING; Labeling	SUPPL	7	AP	2011-06-23
LABELING; Labeling	SUPPL	10	AP	2012-03-13
LABELING; Labeling	SUPPL	13	AP	2013-06-17	STANDARD
LABELING; Labeling	SUPPL	16	AP	2014-04-28	STANDARD
LABELING; Labeling	SUPPL	22	AP	2016-06-23	STANDARD
LABELING; Labeling	SUPPL	29	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	30	AP	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	31	AP	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	32	AP	2019-05-03	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	8
SUPPL	10	Null	8
SUPPL	13	Null	15
SUPPL	16	Null	15
SUPPL	22	Null	15
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	7
SUPPL	32	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

INFORLIFE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78252
            [companyName] => INFORLIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CIPROFLOXACIN","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CIPROFLOXACIN","strength":"400MG\/200ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CIPROFLOXACIN","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CIPROFLOXACIN","actionType":"400MG\/200ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)