BLA 103575

CENTOCOR INC

FDA Drug Application

Application #103575

Documents

• Letter: 2004-03-29
• Letter: 2003-12-04
• Letter: 2013-11-27
• Label: 2004-03-29
• Label: 2004-03-29
• Review: 2004-03-29
• Letter: 2004-03-29
• Letter: 2003-12-04
• Label: 2013-11-26
• Review: 2004-03-29
• Letter: 2019-08-08
• Label: 2019-08-09
• Label: 2019-08-09

Application Sponsors

BLA 103575

CENTOCOR INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

2MG/ML

0

REOPRO

ABCIXIMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1994-12-22	PRIORITY
EFFICACY; Efficacy	SUPPL	1008	AP	1997-11-05	PRIORITY
EFFICACY; Efficacy	SUPPL	1010	AP	1997-11-05	PRIORITY
EFFICACY; Efficacy	SUPPL	1015	AP	2001-01-23	STANDARD
S; Supplement	SUPPL	5022	AP	2003-11-21
LABELING; Labeling	SUPPL	5025	AP	2003-11-21	STANDARD
LABELING; Labeling	SUPPL	5126	AP	2013-11-25	STANDARD
LABELING; Labeling	SUPPL	5138	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	5318	AP	2019-08-07	STANDARD

Submissions Property Types

SUPPL	5022	Null	0
SUPPL	5138	Null	6

CDER Filings

CENTOCOR INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103575
            [companyName] => CENTOCOR INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REOPRO","activeIngredients":"ABCIXIMAB","strength":"2MG\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/07\/2019","submission":"SUPPL-5318","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103575s5318lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2019","submission":"SUPPL-5138","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103575s5138lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2013","submission":"SUPPL-5126","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103575s5126lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/1997","submission":"SUPPL-1010","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/abcicen110597-lab.pdf\"}]","notes":""},{"actionDate":"11\/05\/1997","submission":"SUPPL-1008","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/abcicen110597-lab.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/22\/1994","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/07\/2019","submission":"SUPPL-5318","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103575s5318lbl.pdf\"}]","notes":">"},{"actionDate":"08\/07\/2019","submission":"SUPPL-5138","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103575s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103575Orig1s5138ltr.pdf\"}]","notes":">"},{"actionDate":"11\/25\/2013","submission":"SUPPL-5126","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103575s5126lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103575Orig1s5126ltr.pdf\"}]","notes":">"},{"actionDate":"11\/21\/2003","submission":"SUPPL-5025","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/103575-5025ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/21\/2003","submission":"SUPPL-5022","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/103575-5022ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/23\/2001","submission":"SUPPL-1015","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/1997","submission":"SUPPL-1010","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/abcicen110597-lab.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1997\\\/abcicen110597-ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170113111532\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm093336.htm\"}]","notes":">"},{"actionDate":"11\/05\/1997","submission":"SUPPL-1008","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/abcicen110597-lab.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1997\\\/abcicen110597-ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170113111532\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm093336.htm\"}]","notes":">"}]
            [actionDate] => 2019-08-07
        )

)