BLA 103634

CENTOCOR INC

FDA Drug Application

Application #103634

Documents

• Letter: 2004-03-17
• Label: 2004-03-17
• Review: 2004-03-17

Application Sponsors

BLA 103634

CENTOCOR INC

Marketing Status

• Discontinued: 001

Application Products

001

VIAL

N/A

0

MYOSCINT

IMCIROMAB PENTETATE

FDA Submissions

ORIG

1

AP

1996-07-03

Submissions Property Types

ORIG

1

Null

0

CDER Filings

CENTOCOR INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103634
            [companyName] => CENTOCOR INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYOSCINT","activeIngredients":"IMCIROMAB PENTETATE","strength":"N\/A","dosageForm":"VIAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/03\/1996","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1996\\\/imcicen070396-lab.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/03\/1996","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1996\\\/imcicen070396-lab.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1996\\\/imcicen070396L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20120303004254\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080665.htm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 1996-07-03
        )

)