FDA.reportPublic FDA data

Application 125084

Type
BLA
Sponsor
IMCLONE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERBITUXCETUXIMABVIAL; INTRAVENOUS100mg/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-948ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent
66733-958ERBITUXcetuximabImClone LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68807SUPPL2021-09-29
68798SUPPL2021-09-28
67472SUPPL2021-05-12
67471SUPPL2021-05-12
67002SUPPL2021-04-07
67001SUPPL2021-04-07
66998SUPPL2021-04-07
66997SUPPL2021-04-07
65206SUPPL2020-11-13
65184SUPPL2020-11-12
58426SUPPL2019-04-26
58407SUPPL2019-04-25
54469SUPPL2018-06-06
54459SUPPL2018-06-05
54042SUPPL2018-05-08
54020SUPPL2018-05-04
47280SUPPL2017-02-22
45540SUPPL2016-10-14
18770SUPPL2015-04-14
9588SUPPL2015-04-13
39820SUPPL2015-03-12
31810SUPPL2015-03-12
18769SUPPL2013-03-08
31809SUPPL2013-03-05
31808SUPPL2012-07-09
39818SUPPL2012-07-06
39819SUPPL2012-03-20
18768SUPPL2012-02-16
9587SUPPL2012-01-31
9586SUPPL2012-01-31
43302SUPPL2011-12-02
31806SUPPL2011-11-08
18766SUPPL2011-11-07
22779SUPPL2011-01-04
31807SUPPL2009-08-12
18767SUPPL2009-08-06
39817SUPPL2009-07-20
31805SUPPL2008-09-16
9585SUPPL2007-10-10
18765SUPPL2007-10-05
31804SUPPL2006-05-25
39816SUPPL2006-05-23
18764SUPPL2006-04-21
9584SUPPL2006-04-21
39815SUPPL2005-09-08
31803SUPPL2005-09-08
44426ORIG2005-04-15
22778ORIG2004-09-13
9583SUPPL2004-06-24
31802ORIG2004-04-08
18763ORIG2004-02-12
44562ORIG2004-02-11