PHARMACIA AND UPJOHN FDA Approval ANDA 060751

ANDA 060751

PHARMACIA AND UPJOHN

FDA Drug Application

Application #060751

Application Sponsors

ANDA 060751PHARMACIA AND UPJOHN

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001OINTMENT;TOPICAL0.5%;EQ 3.5MG BASE/GM0NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATE
002OINTMENT;TOPICAL1%;EQ 3.5MG BASE/GM0NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATE
003OINTMENT;TOPICAL2.5%;EQ 3.5MG BASE/GM0NEO-CORTEFHYDROCORTISONE ACETATE; NEOMYCIN SULFATE

FDA Submissions

ORIG1AP1965-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1991-03-04
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1992-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1991-04-22
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1993-01-22

Submissions Property Types

SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0

CDER Filings

PHARMACIA AND UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60751
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEO-CORTEF","activeIngredients":"HYDROCORTISONE ACETATE; NEOMYCIN SULFATE","strength":"0.5%;EQ 3.5MG BASE\/GM","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEO-CORTEF","activeIngredients":"HYDROCORTISONE ACETATE; NEOMYCIN SULFATE","strength":"1%;EQ 3.5MG BASE\/GM","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEO-CORTEF","activeIngredients":"HYDROCORTISONE ACETATE; NEOMYCIN SULFATE","strength":"2.5%;EQ 3.5MG BASE\/GM","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEO-CORTEF","submission":"HYDROCORTISONE ACETATE; NEOMYCIN SULFATE","actionType":"0.5%;EQ 3.5MG BASE\/GM","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEO-CORTEF","submission":"HYDROCORTISONE ACETATE; NEOMYCIN SULFATE","actionType":"1%;EQ 3.5MG BASE\/GM","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEO-CORTEF","submission":"HYDROCORTISONE ACETATE; NEOMYCIN SULFATE","actionType":"2.5%;EQ 3.5MG BASE\/GM","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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