BAUSCH AND LOMB FDA Approval ANDA 074805

ANDA 074805

BAUSCH AND LOMB

FDA Drug Application

Application #074805

Documents

Letter2003-04-09

Application Sponsors

ANDA 074805BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001SPRAY, METERED;NASAL0.025MG/SPRAY0FLUNISOLIDEFLUNISOLIDE

FDA Submissions

ORIG1AP2002-02-20
LABELING; LabelingSUPPL3AP2004-05-18

TE Codes

001PrescriptionAB

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74805
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUNISOLIDE","activeIngredients":"FLUNISOLIDE","strength":"0.025MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUNISOLIDE","submission":"FLUNISOLIDE","actionType":"0.025MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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