ANDA 062452

ALLERGAN

FDA Drug Application

Application #062452

Application Sponsors

ANDA 062452

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.3% BASE

0

GENOPTIC

GENTAMICIN SULFATE

FDA Submissions

	ORIG	1	AP	1984-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1991-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-02-26
LABELING; Labeling	SUPPL	8	AP	1992-02-28
LABELING; Labeling	SUPPL	9	AP	1993-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-07-01
LABELING; Labeling	SUPPL	12	AP	1995-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-12-08
LABELING; Labeling	SUPPL	19	AP	2004-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-11-15

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62452
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENOPTIC","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 0.3% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GENOPTIC","submission":"GENTAMICIN SULFATE","actionType":"EQ 0.3% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)