ALLERGAN FDA Approval NDA 019814

NDA 019814

ALLERGAN

FDA Drug Application

Application #019814

Documents

Label2003-06-10
Label2003-06-10

Application Sponsors

NDA 019814ALLERGAN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.25%1BETAGANLEVOBUNOLOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1989-06-28STANDARD
LABELING; LabelingSUPPL2AP1990-01-18
LABELING; LabelingSUPPL3AP1992-02-03
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1995-08-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1995-06-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1995-06-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-01-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1997-09-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-05-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-10-02STANDARD
LABELING; LabelingSUPPL11AP2001-05-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-08-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-04-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-12-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-04-12STANDARD
LABELING; LabelingSUPPL17AP2003-03-19STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0

TE Codes

001PrescriptionAT

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19814
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAGAN","activeIngredients":"LEVOBUNOLOL HYDROCHLORIDE","strength":"0.25%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/08\/2001","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19814s12lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/14\/2001","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19814S11lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BETAGAN","submission":"LEVOBUNOLOL HYDROCHLORIDE","actionType":"0.25%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2001-08-08
        )

)

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