ALCON FDA Approval NDA 020226

NDA 020226

ALCON

FDA Drug Application

Application #020226

Documents

Letter2019-04-12
Label2019-04-15
Label2022-12-20
Letter2022-12-21

Application Sponsors

NDA 020226ALCON

Marketing Status

Over-the-counter001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.025%;0.3%1NAPHCON-ANAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP1994-06-08STANDARD
LABELING; LabelingSUPPL2AP1995-02-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1995-11-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1995-11-01STANDARD
LABELING; LabelingSUPPL5AP1996-07-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1996-04-16STANDARD
LABELING; LabelingSUPPL7AP1996-09-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1997-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-08-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-12-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-06-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1999-10-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1999-11-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2000-01-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-03-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2000-09-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2001-03-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-12-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2014-06-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2015-07-31STANDARD
LABELING; LabelingSUPPL29AP2019-04-11STANDARD
LABELING; LabelingSUPPL35AP2022-12-19STANDARD

Submissions Property Types

SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL22Null0
SUPPL24Null0
SUPPL29Null7
SUPPL35Null6

CDER Filings

ALCON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20226
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPHCON-A","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","strength":"0.025%;0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/11\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020226Orig1s029lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NAPHCON-A","submission":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","actionType":"0.025%;0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-04-11
        )

)

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