ANDA 078431

HIKMA FARMACEUTICA

FDA Drug Application

Application #078431

Application Sponsors

ANDA 078431

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

400MG/200ML

0

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

CIPROFLOXACIN

FDA Submissions

	ORIG	1	AP	2009-11-18
LABELING; Labeling	SUPPL	4	AP	2014-06-25	STANDARD
LABELING; Labeling	SUPPL	6	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	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-05-03	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78431
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"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":"400MG\/200ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)