CENTOCOR INC FDA Approval BLA 103772

Application #103772

Documents

Letter	2004-09-22
Letter	2004-03-26
Letter	2004-03-26
Letter	2003-11-03
Letter	2004-03-26
Letter	2004-08-10
Letter	2005-04-12
Letter	2005-10-20
Letter	2006-10-23
Letter	2007-01-08
Letter	2006-08-14
Letter	2009-04-20
Letter	2009-11-25
Letter	2011-02-28
Letter	2011-09-29
Letter	2011-08-11
Letter	2012-06-29
Letter	2013-11-08
Letter	2015-09-01
Label	2004-03-26
Label	2004-03-26
Label	2004-08-10
Label	2004-09-29
Label	2005-09-20
Label	2007-02-23
Label	2006-05-19
Label	2006-10-23
Label	2007-01-08
Label	2006-08-18
Label	2007-07-05
Label	2009-05-07
Label	2010-08-28
Label	2011-03-04
Label	2012-03-15
Label	2013-11-08
Label	2015-10-08
Label	2015-08-28
Review	2007-08-06
Review	2016-01-19
Review	2012-02-14
Patient Package Insert	2004-09-29
Letter	2004-03-26
Letter	2004-03-26
Letter	2003-11-03
Letter	2004-10-05
Letter	2004-12-29
Letter	2005-05-20
Letter	2005-03-03
Letter	2007-02-12
Letter	2006-05-19
Letter	2007-04-25
Letter	2006-08-14
Letter	2007-07-05
Letter	2009-05-08
Letter	2011-01-06
Letter	2010-05-10
Letter	2010-08-03
Letter	2013-03-29
Letter	2015-01-07
Letter	2015-10-06
Label	2004-09-22
Label	2004-03-26
Label	2004-03-26
Label	2004-12-29
Label	2005-05-20
Label	2005-04-12
Label	2007-04-25
Label	2006-08-18
Label	2009-04-20
Label	2011-01-06
Label	2010-05-07
Label	2011-09-30
Label	2013-04-01
Label	2015-01-05
Review	2004-09-22
Review	2004-03-26
Review	2008-04-02
Other Important Information from FDA	2006-05-19
Label	2017-10-26
Letter	2017-10-30
Letter	2018-06-21
Label	2018-06-26
Medication Guide	2018-06-26
Label	2020-05-15
Medication Guide	2020-05-15
Label	2020-05-15
Medication Guide	2020-05-15
Label	2020-05-15
Medication Guide	2020-05-15
Letter	2020-05-15
Letter	2020-05-15
Letter	2020-05-15
Label	2021-10-06
Medication Guide	2021-10-06
Letter	2021-12-29

Application Sponsors

BLA 103772

CENTOCOR INC

Marketing Status

Prescription

001

Application Products

001

VIAL

100MG

REMICADE

INFLIXIMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-08-24	PRIORITY
EFFICACY; Efficacy	SUPPL	1004	AP	1999-11-10	STANDARD
EFFICACY; Efficacy	SUPPL	1007	AP	2000-12-29	PRIORITY
EFFICACY; Efficacy	SUPPL	5004	AP	2002-02-27	STANDARD
LABELING; Labeling	SUPPL	5006	AP	2001-11-27	STANDARD
EFFICACY; Efficacy	SUPPL	5012	AP	2002-06-28	PRIORITY
LABELING; Labeling	SUPPL	5020	AP	2003-09-03	STANDARD
EFFICACY; Efficacy	SUPPL	5032	AP	2003-04-01	PRIORITY
LABELING; Labeling	SUPPL	5047	AP	2003-07-14	STANDARD
LABELING; Labeling	SUPPL	5049	AP	2003-07-03	STANDARD
LABELING; Labeling	SUPPL	5056	AP	2003-09-03	STANDARD
LABELING; Labeling	SUPPL	5058	AP	2004-07-29	STANDARD
LABELING; Labeling	SUPPL	5069	AP	2004-03-10	STANDARD
EFFICACY; Efficacy	SUPPL	5073	AP	2004-09-29	STANDARD
EFFICACY; Efficacy	SUPPL	5077	AP	2004-12-17	STANDARD
LABELING; Labeling	SUPPL	5083	AP	2004-10-07	STANDARD
EFFICACY; Efficacy	SUPPL	5089	AP	2005-05-13	STANDARD
LABELING; Labeling	SUPPL	5090	AP	2004-12-17	STANDARD
LABELING; Labeling	SUPPL	5092	AP	2005-04-05	STANDARD
EFFICACY; Efficacy	SUPPL	5113	AP	2005-09-15	PRIORITY
EFFICACY; Efficacy	SUPPL	5129	AP	2006-09-26	STANDARD
LABELING; Labeling	SUPPL	5135	AP	2006-03-17	STANDARD
EFFICACY; Efficacy	SUPPL	5138	AP	2006-05-19	PRIORITY
EFFICACY; Efficacy	SUPPL	5145	AP	2006-10-13	STANDARD
EFFICACY; Efficacy	SUPPL	5160	AP	2007-04-19	STANDARD
LABELING; Labeling	SUPPL	5163	AP	2006-12-08	STANDARD
EFFICACY; Efficacy	SUPPL	5166	AP	2006-08-11	STANDARD
EFFICACY; Efficacy	SUPPL	5167	AP	2006-08-11	STANDARD
LABELING; Labeling	SUPPL	5189	AP	2007-06-12	STANDARD
LABELING; Labeling	SUPPL	5206	AP	2008-05-19	STANDARD
LABELING; Labeling	SUPPL	5208	AP	2008-08-06	STANDARD
LABELING; Labeling	SUPPL	5232	AP	2008-12-22	STANDARD
S; Supplement	SUPPL	5234	AP	2009-05-05
LABELING; Labeling	SUPPL	5258	AP	2009-11-18	STANDARD
LABELING; Labeling	SUPPL	5259	AP	2010-12-28	STANDARD
LABELING; Labeling	SUPPL	5260	AP	2010-04-26	STANDARD
LABELING; Labeling	SUPPL	5278	AP	2010-07-29	STANDARD
LABELING; Labeling	SUPPL	5281	AP	2011-02-17	STANDARD
LABELING; Labeling	SUPPL	5285	AP	2010-10-04	STANDARD
LABELING; Labeling	SUPPL	5295	AP	2011-10-26	STANDARD
EFFICACY; Efficacy	SUPPL	5301	AP	2011-09-23	PRIORITY
LABELING; Labeling	SUPPL	5314	AP	2011-09-07	STANDARD
S; Supplement	SUPPL	5317	AP	2011-08-01
LABELING; Labeling	SUPPL	5328	AP	2012-06-28	STANDARD
LABELING; Labeling	SUPPL	5345	AP	2013-03-28	STANDARD
LABELING; Labeling	SUPPL	5359	AP	2013-11-06	STANDARD
LABELING; Labeling	SUPPL	5370	AP	2015-01-02	STANDARD
LABELING; Labeling	SUPPL	5373	AP	2015-10-02	STANDARD
LABELING; Labeling	SUPPL	5374	AP	2015-08-27	STANDARD
LABELING; Labeling	SUPPL	5377	AP	2017-10-25	STANDARD
LABELING; Labeling	SUPPL	5385	AP	2018-06-19	STANDARD
LABELING; Labeling	SUPPL	5389	AP	2020-05-14	STANDARD
LABELING; Labeling	SUPPL	5391	AP	2020-05-14	STANDARD
LABELING; Labeling	SUPPL	5394	AP	2020-05-14	STANDARD
LABELING; Labeling	SUPPL	5401	AP	2021-10-05	STANDARD

Submissions Property Types

ORIG	1	Null	27
SUPPL	1007	Null	2
SUPPL	5032	Orphan	5
SUPPL	5113	Null	2
SUPPL	5138	Orphan	5
SUPPL	5145	Null	2
SUPPL	5160	Orphan	5
SUPPL	5234	Null	0
SUPPL	5258	Null	7
SUPPL	5295	Null	7
SUPPL	5301	Orphan	5
SUPPL	5317	Null	0
SUPPL	5370	Null	15
SUPPL	5373	Null	7
SUPPL	5374	Null	15
SUPPL	5377	Null	7
SUPPL	5385	Null	7
SUPPL	5389	Null	7
SUPPL	5391	Null	7
SUPPL	5394	Null	6
SUPPL	5401	Null	6

CDER Filings

CENTOCOR INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103772
            [companyName] => CENTOCOR INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/103772s5389s5391s5394lbl.pdf#page=50"]
            [products] => [{"drugName":"REMICADE","activeIngredients":"INFLIXIMAB","strength":"100MG","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-5394","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2020","submission":"SUPPL-5391","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2020","submission":"SUPPL-5391","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2020","submission":"SUPPL-5389","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2020","submission":"SUPPL-5389","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2018","submission":"SUPPL-5385","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103772s5385lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2017","submission":"SUPPL-5377","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103772s5370lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2013","submission":"SUPPL-5359","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103772s5359lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2013","submission":"SUPPL-5345","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103772s5345lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2011","submission":"SUPPL-5295","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103772s5295lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2011","submission":"SUPPL-5301","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103772s5301lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2011","submission":"SUPPL-5281","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103772s5281lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2010","submission":"SUPPL-5259","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103772s5259lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2010","submission":"SUPPL-5260","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103772s5260lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2009","submission":"SUPPL-5258","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/103772s5258lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2009","submission":"SUPPL-5234","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/103772s5234lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2008","submission":"SUPPL-5232","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103772s5232lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2007","submission":"SUPPL-5189","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103772s5189lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2007","submission":"SUPPL-5160","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103772s5160_LBL.pdf\"}]","notes":""},{"actionDate":"12\/08\/2006","submission":"SUPPL-5163","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103772s5163lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-5145","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103772s5145LBL.pdf\"}]","notes":""},{"actionDate":"09\/26\/2006","submission":"SUPPL-5129","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103772s5129lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2006","submission":"SUPPL-5167","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"08\/11\/2006","submission":"SUPPL-5166","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"05\/19\/2006","submission":"SUPPL-5138","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103772s5138lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2005","submission":"SUPPL-5113","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103772s5113lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2005","submission":"SUPPL-5089","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103772s5089lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2005","submission":"SUPPL-5092","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103772_5092_LBL.pdf\"}]","notes":""},{"actionDate":"12\/17\/2004","submission":"SUPPL-5077","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103772_5077_lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2004","submission":"SUPPL-5073","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103772s5073lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2004","submission":"SUPPL-5058","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103772_5058lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2002","submission":"SUPPL-5012","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/inflcen062802LB.pdf\"}]","notes":""},{"actionDate":"02\/27\/2002","submission":"SUPPL-5004","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/inflcen022702LB.pdf\"}]","notes":""},{"actionDate":"12\/29\/2000","submission":"SUPPL-1007","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/inflcen122900LB.pdf\"}]","notes":""},{"actionDate":"11\/10\/1999","submission":"SUPPL-1004","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/inflcen111099lb.pdf\"}]","notes":""},{"actionDate":"08\/24\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/inflcen082498lb.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/24\/1998","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/inflcen082498lb.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1998\\\/inflcen082498L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170118085130\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm093327.htm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-5394","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103772Orig1s5389,s5391,s5394ltr.pdf\"}]","notes":">"},{"actionDate":"05\/14\/2020","submission":"SUPPL-5391","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103772Orig1s5389,s5391,s5394ltr.pdf\"}]","notes":">"},{"actionDate":"05\/14\/2020","submission":"SUPPL-5389","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103772s5389s5391s5394lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103772Orig1s5389,s5391,s5394ltr.pdf\"}]","notes":">"},{"actionDate":"06\/19\/2018","submission":"SUPPL-5385","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103772s5385lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103772Orig1s5385ltr.pdf\"}]","notes":">"},{"actionDate":"10\/25\/2017","submission":"SUPPL-5377","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103772s5377lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103772Orig1s05377ltr.pdf\"}]","notes":">"},{"actionDate":"08\/27\/2015","submission":"SUPPL-5374","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103772s5374lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103772Orig1s5374ltr.pdf\"}]","notes":">"},{"actionDate":"10\/02\/2015","submission":"SUPPL-5373","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103772s5373lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103772Orig1s5373ltr.pdf\"}]","notes":">"},{"actionDate":"01\/02\/2015","submission":"SUPPL-5370","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103772s5370lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103772Orig1s5370ltr.pdf\"}]","notes":">"},{"actionDate":"11\/06\/2013","submission":"SUPPL-5359","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103772s5359lbl.pdf\"},{\"name\":\"Letter 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site."},{"actionDate":"04\/26\/2010","submission":"SUPPL-5260","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103772s5260lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103772s5260ltr.pdf\"}]","notes":">"},{"actionDate":"12\/28\/2010","submission":"SUPPL-5259","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103772s5259lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103772s5259ltr.pdf\"}]","notes":">"},{"actionDate":"11\/18\/2009","submission":"SUPPL-5258","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label 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site."},{"actionDate":"12\/17\/2004","submission":"SUPPL-5077","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103772_5077_lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/103772_5077_ltr.pdf\"}]","notes":">"},{"actionDate":"09\/29\/2004","submission":"SUPPL-5073","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103772s5073lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/103772_5073ltr.pdf\"},{\"name\":\"Patient Package Insert 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            [actionDate] => 2020-05-14
        )

)

BLA 103772

CENTOCOR INC

FDA Drug Application

Application #103772

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

CENTOCOR INC