FDA.reportPublic FDA data

Application 125418

Type
BLA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZALTRAPZIV-AFLIBERCEPTINJECTABLE; INJECTION4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5840ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5840ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5840ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5840ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5840ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5841ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5841ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5841ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5841ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent
0024-5841ZALTRAPziv-afliberceptsanofi-aventis U.S. LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76824SUPPL 2023-12-14
76794SUPPL 2023-12-14
63446SUPPL2020-06-08
63438SUPPL2020-06-08
62134SUPPL2020-03-12
62132SUPPL2020-03-12
61099SUPPL2019-11-29
61075SUPPL2019-11-27
39956SUPPL2016-06-27
9744SUPPL2016-06-27
18912SUPPL2016-03-14
31965SUPPL2016-03-11
9743SUPPL2015-09-18
39955SUPPL2013-10-31
31964SUPPL2013-10-28
44807ORIG2012-09-06
22808ORIG2012-09-06
31963ORIG2012-08-03
18911ORIG2012-08-03