BAUSCH AND LOMB FDA Approval ANDA 064055

ANDA 064055

BAUSCH AND LOMB

FDA Drug Application

Application #064055

Application Sponsors

ANDA 064055BAUSCH AND LOMB

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML0NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

FDA Submissions

ORIG1AP1995-10-30

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64055
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE","strength":"EQ 0.1% PHOSPHATE;EQ 3.5MG BASE\/ML","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE","submission":"DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE","actionType":"EQ 0.1% PHOSPHATE;EQ 3.5MG BASE\/ML","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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