ANDA 078559

FDC LTD

FDA Drug Application

Application #078559

Documents

• Healthcare Professional Sheet: 2009-03-03

Application Sponsors

ANDA 078559

FDC LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.3%

0

OFLOXACIN

OFLOXACIN

FDA Submissions

	ORIG	1	AP	2009-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-03-12	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	2020-07-02	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AT

CDER Filings

FDC LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78559
            [companyName] => FDC LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OFLOXACIN","activeIngredients":"OFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OFLOXACIN","submission":"OFLOXACIN","actionType":"0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)