ALLERGAN FDA Approval NDA 019216

NDA 019216

ALLERGAN

FDA Drug Application

Application #019216

Documents

Letter2006-01-20
Label2006-01-13
Letter2006-01-20
Letter2013-02-13
Label2006-01-13
Label2013-02-14

Application Sponsors

NDA 019216ALLERGAN

Marketing Status

Prescription001

Application Products

001SUSPENSION/DROPS;OPHTHALMIC0.25%1FML FORTEFLUOROMETHOLONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1986-04-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-08-28STANDARD
LABELING; LabelingSUPPL3AP1990-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1989-10-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1989-10-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1990-02-27STANDARD
LABELING; LabelingSUPPL7AP1992-05-21
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1993-09-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1995-08-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1994-12-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1996-12-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1998-05-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-10-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1998-09-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-10-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-04-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2001-09-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2001-12-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2002-04-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2002-09-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2006-01-10STANDARD
LABELING; LabelingSUPPL22AP2006-01-10STANDARD
LABELING; LabelingSUPPL25AP2013-02-12STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL25Null15

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19216
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FML FORTE","activeIngredients":"FLUOROMETHOLONE","strength":"0.25%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/12\/2013","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019216s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2006","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019216s021s022lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2006","submission":"SUPPL-21","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019216s021s022lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FML FORTE","submission":"FLUOROMETHOLONE","actionType":"0.25%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-02-12
        )

)

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