ANDA 078792

BAUSCH AND LOMB

FDA Drug Application

Application #078792

Application Sponsors

ANDA 078792

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.1%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

	ORIG	1	AP	2007-12-28
LABELING; Labeling	SUPPL	6	AP	2013-09-30	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	6	Null	15

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78792
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)