ANDA 064135

BAUSCH AND LOMB

FDA Drug Application

Application #064135

Application Sponsors

ANDA 064135

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

0

DEXASPORIN

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

	ORIG	1	AP	1995-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-02-05
LABELING; Labeling	SUPPL	34	AP	2020-02-07	STANDARD

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
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	34	Null	15

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64135
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXASPORIN","activeIngredients":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"0.1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXASPORIN","submission":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"0.1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)