ANDA 064046

BAUSCH AND LOMB

FDA Drug Application

Application #064046

Application Sponsors

ANDA 064046

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;OPHTHALMIC

500 UNITS/GM;10,000 UNITS/GM

0

BACITRACIN ZINC AND POLYMYXIN B SULFATE

BACITRACIN ZINC; POLYMYXIN B SULFATE

FDA Submissions

	ORIG	1	AP	1995-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-06-07
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	2001-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-08-05

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	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

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64046
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACITRACIN ZINC AND POLYMYXIN B SULFATE","activeIngredients":"BACITRACIN ZINC; POLYMYXIN B SULFATE","strength":"500 UNITS\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACITRACIN ZINC AND POLYMYXIN B SULFATE","submission":"BACITRACIN ZINC; POLYMYXIN B SULFATE","actionType":"500 UNITS\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)