PHARMACIA AND UPJOHN FDA Approval ANDA 060611

ANDA 060611

PHARMACIA AND UPJOHN

FDA Drug Application

Application #060611

Application Sponsors

ANDA 060611PHARMACIA AND UPJOHN

Marketing Status

Discontinued001
Discontinued002

Application Products

001CREAM;TOPICAL1%;EQ 3.5MG BASE/GM0NEO-MEDROL ACETATEMETHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE
002CREAM;TOPICAL0.25%;EQ 3.5MG BASE/GM0NEO-MEDROL ACETATEMETHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE

FDA Submissions

ORIG1AP1964-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1991-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1993-01-22

Submissions Property Types

ORIG1Null0
SUPPL4Null0
SUPPL5Null0

CDER Filings

PHARMACIA AND UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60611
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEO-MEDROL ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE","strength":"1%;EQ 3.5MG BASE\/GM","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEO-MEDROL ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE","strength":"0.25%;EQ 3.5MG BASE\/GM","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEO-MEDROL ACETATE","submission":"METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE","actionType":"1%;EQ 3.5MG BASE\/GM","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEO-MEDROL ACETATE","submission":"METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE","actionType":"0.25%;EQ 3.5MG BASE\/GM","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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