ALCON FDA Approval ANDA 080021

ANDA 080021

ALCON

FDA Drug Application

Application #080021

Application Sponsors

ANDA 080021ALCON

Marketing Status

Discontinued001

Application Products

001OINTMENT;OPHTHALMIC10%0CETAMIDESULFACETAMIDE SODIUM

FDA Submissions

ORIG1AP1972-09-27
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1990-03-09
LABELING; LabelingSUPPL6AP1989-09-15
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1990-03-09
LABELING; LabelingSUPPL8AP1991-07-05
LABELING; LabelingSUPPL9AP1993-08-31
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1992-08-19
LABELING; LabelingSUPPL11AP1993-08-31
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1994-08-23
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1996-04-18
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1996-04-18
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1996-12-12
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1999-03-23
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-01-18

Submissions Property Types

SUPPL1Null0
SUPPL5Null0
SUPPL7Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0

CDER Filings

ALCON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80021
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETAMIDE","activeIngredients":"SULFACETAMIDE SODIUM","strength":"10%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CETAMIDE","submission":"SULFACETAMIDE SODIUM","actionType":"10%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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