ANDA 074449

BAUSCH AND LOMB

FDA Drug Application

Application #074449

Application Sponsors

ANDA 074449

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.23% PHOSPHATE;10%

0

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

FDA Submissions

	ORIG	1	AP	1995-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-11-27

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74449
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM","strength":"EQ 0.23% PHOSPHATE;10%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE","submission":"PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM","actionType":"EQ 0.23% PHOSPHATE;10%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)