FDA.reportPublic FDA data

Application 022065

Type
NDA
Sponsor
R-PHARM US LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IXEMPRA KITIXABEPILONEINJECTABLE;INTRAVENOUS15MG/VIALYesYes
002IXEMPRA KITIXABEPILONEINJECTABLE;INTRAVENOUS45MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70020-1910IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1910IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1910IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1910IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1910IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1910IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1910IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1911IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1911IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1911IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1911IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1911IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1911IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent
70020-1911IXEMPRAixabepiloneR-Pharm US Operating, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73147SUPPL2023-01-13
73144SUPPL2023-01-12
69967SUPPL2022-01-25
69956SUPPL2022-01-25
38177SUPPL2011-10-20
6805SUPPL2011-10-20
52939SUPPL2011-04-05
52938SUPPL2011-04-05
52937SUPPL2011-04-05
51943SUPPL2011-04-05
51942SUPPL2011-04-05
51941SUPPL2011-04-05
38176SUPPL2010-05-17
38175SUPPL2010-05-17
29186SUPPL2010-05-17
6804SUPPL2010-05-17
29185SUPPL2009-10-13
6803SUPPL2009-10-13
16875SUPPL2009-10-07
16874SUPPL2009-10-07
38174SUPPL2009-04-03
6802SUPPL2009-03-17
42406ORIG2008-03-24
29184ORIG2007-10-22
16873ORIG2007-10-17
64238SUPPL1900-01-01