FDA.reportPublic FDA data

Application 761103

Type
BLA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RUXIENCERITUXIMAB-PVVRINJECTABLE;INJECTION100MG/10ML(10MG/ML)NoNo
002RUXIENCERITUXIMAB-PVVRINJECTABLE;INJECTION500MG/50ML(10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0238Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0238Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0238Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0249Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0249Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0249Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82525SUPPL 2025-06-10
82524SUPPL 2025-06-10
75866SUPPL 2023-10-20
75831SUPPL 2023-10-17
69336SUPPL2021-11-17
69321SUPPL2021-11-16
69320SUPPL2021-11-16
63330SUPPL2020-05-29
63307SUPPL2020-05-27
63306SUPPL2020-05-27
59773ORIG2019-08-20
59442ORIG2019-08-20
59406ORIG2019-07-23
59405ORIG2019-07-23