ANDA 077568

FDC LTD

FDA Drug Application

Application #077568

Application Sponsors

ANDA 077568

FDC LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.3% BASE

0

CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-06-30
LABELING; Labeling	SUPPL	6	AP	2015-03-16

Submissions Property Types

SUPPL

6

Null

15

TE Codes

001

Prescription

AT

CDER Filings

FDC LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77568
            [companyName] => FDC LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 0.3% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 0.3% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)