CMP PHARMA INC FDA Approval ANDA 088138

ANDA 088138

CMP PHARMA INC

FDA Drug Application

Application #088138

Application Sponsors

ANDA 088138CMP PHARMA INC

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL1%0HYDROCORTISONE IN ABSORBASEHYDROCORTISONE

FDA Submissions

ORIG1AP1985-09-06
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-09-05
LABELING; LabelingSUPPL7AP1991-01-07

Submissions Property Types

SUPPL1Null0
SUPPL2Null0

TE Codes

001PrescriptionAT

CDER Filings

CMP PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88138
            [companyName] => CMP PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE IN ABSORBASE","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE IN ABSORBASE","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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