ALLERGAN FDA Approval ANDA 062452

ANDA 062452

ALLERGAN

FDA Drug Application

Application #062452

Application Sponsors

ANDA 062452ALLERGAN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.3% BASE0GENOPTICGENTAMICIN SULFATE

FDA Submissions

ORIG1AP1984-10-10
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1988-11-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1991-04-11
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1989-04-05
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1991-02-26
LABELING; LabelingSUPPL8AP1992-02-28
LABELING; LabelingSUPPL9AP1993-09-27
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1994-09-27
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1994-07-01
LABELING; LabelingSUPPL12AP1995-01-31
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1998-04-03
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-10-22
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1998-02-24
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1998-10-16
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-12-08
LABELING; LabelingSUPPL19AP2004-02-20
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2001-08-15
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2002-07-03
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2002-11-15

Submissions Property Types

SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL10Null0
SUPPL11Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0

TE Codes

001PrescriptionAT

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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.