FDA.reportPublic FDA data

Application 103946

Type
BLA
Sponsor
SANOFI SYNTHELABO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELITEKRASBURICASEVIAL; INTRAVENOUS1.5MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5150Elitekrasburicasesanofi-aventis U.S. LLCBLACurrent
0024-5150ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5150ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5150ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5151ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5151ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5151ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61272SUPPL2019-12-13
61263SUPPL2019-12-13
49778SUPPL2017-09-19
49759SUPPL2017-09-18
39735SUPPL2016-06-17
31696SUPPL2016-06-15
39734SUPPL2015-05-27
31695SUPPL2015-05-26
9493SUPPL2015-02-12
31694SUPPL2009-10-26
39733SUPPL2009-10-19
31693SUPPL2007-10-04
18673SUPPL2007-10-04
39732SUPPL2005-01-26
9492SUPPL2005-01-26
43292ORIG2004-03-12
39731ORIG2004-03-12
9491ORIG2004-03-12