FDA.reportPublic FDA data

Application 021660

Type
NDA
Sponsor
ABRAXIS BIOSCIENCE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABRAXANEPACLITAXELFOR SUSPENSION;IV (INFUSION)100MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-710Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)PaclitaxelTWi Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
60505-6230Paclitaxel protein-bound particles for injectable suspension (albumin-bound)PaclitaxelApotex Corp.NDA AUTHORIZED GENERICCurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent
68817-134ABRAXANEPaclitaxelAbraxis BioScience, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64423SUPPL2020-08-26
64415SUPPL2020-08-26
61204SUPPL2019-12-10
61188SUPPL2019-12-09
58216SUPPL2019-04-04
57205SUPPL2019-01-14
57204SUPPL2019-01-14
57203SUPPL2019-01-14
55205SUPPL2018-08-20
55203SUPPL2018-08-17
37422SUPPL2015-07-22
28329SUPPL2015-07-22
42259SUPPL2015-03-09
15938SUPPL2015-01-08
5943SUPPL2014-12-12
37421SUPPL2013-10-31
5942SUPPL2013-10-31
28328SUPPL2013-09-10
37420SUPPL2013-09-06
28327SUPPL2013-06-11
15937SUPPL2013-06-11
5940SUPPL2012-10-15
37418SUPPL2012-10-12
37419SUPPL2012-10-04
15936SUPPL2012-10-04
28326SUPPL2012-10-03
5941SUPPL2012-10-03
42257SUPPL2012-09-17
42258SUPPL2012-03-27
21770SUPPL2012-03-27
37417SUPPL2012-01-26
37416SUPPL2012-01-26
15935SUPPL2012-01-26
28325SUPPL2012-01-03
28324SUPPL2012-01-03
5939SUPPL2012-01-03
5938SUPPL2009-06-30
37415SUPPL2009-06-29
37414SUPPL2008-07-09
5937SUPPL2008-07-07
37413SUPPL2007-02-23
5936SUPPL2007-02-23
21769ORIG2005-06-16
5935ORIG2005-01-11
37412ORIG2005-01-10
64030ORIG1900-01-01
64029ORIG1900-01-01
64028ORIG1900-01-01
64027ORIG1900-01-01
63215SUPPL1900-01-01