PHARMACIA AND UPJOHN FDA Approval ANDA 061039

ANDA 061039

PHARMACIA AND UPJOHN

FDA Drug Application

Application #061039

Application Sponsors

ANDA 061039PHARMACIA AND UPJOHN

Marketing Status

Discontinued001
Discontinued002

Application Products

001OINTMENT;OPHTHALMICEQ 3.5MG BASE/GM;0.5%0NEO-DELTA-CORTEFNEOMYCIN SULFATE; PREDNISOLONE ACETATE
002OINTMENT;OPHTHALMICEQ 3.5MG BASE/GM;0.25%0NEO-DELTA-CORTEFNEOMYCIN SULFATE; PREDNISOLONE ACETATE

CDER Filings

PHARMACIA AND UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61039
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEO-DELTA-CORTEF","activeIngredients":"NEOMYCIN SULFATE; PREDNISOLONE ACETATE","strength":"EQ 3.5MG BASE\/GM;0.5%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEO-DELTA-CORTEF","activeIngredients":"NEOMYCIN SULFATE; PREDNISOLONE ACETATE","strength":"EQ 3.5MG BASE\/GM;0.25%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEO-DELTA-CORTEF","submission":"NEOMYCIN SULFATE; PREDNISOLONE ACETATE","actionType":"EQ 3.5MG BASE\/GM;0.5%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEO-DELTA-CORTEF","submission":"NEOMYCIN SULFATE; PREDNISOLONE ACETATE","actionType":"EQ 3.5MG BASE\/GM;0.25%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.