FDA.reportPublic FDA data

Application 761081

Type
BLA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAZIMERATRASTUZUMAB-QYYPINJECTABLE;INJECTION420MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0305Trazimera-qyyptrastuzumabPfizer Laboratories Div Pfizer IncBLACurrent
0069-0305Trazimeratrastuzumab-qyypPfizer Laboratories Div Pfizer IncBLACurrent
0069-0305Trazimeratrastuzumab-qyypPfizer Laboratories Div Pfizer IncBLACurrent
0069-0305Trazimeratrastuzumab-qyypPfizer Laboratories Div Pfizer IncBLACurrent
0069-0305Trazimera-qyyptrastuzumabPfizer Laboratories Div Pfizer IncBLACurrent
0069-0305Trazimeratrastuzumab-qyypPfizer Laboratories Div Pfizer IncBLACurrent
0069-0308Trazimeratrastuzumab-qyypPfizer Laboratories Div Pfizer IncBLACurrent
0069-0308Trazimeratrastuzumab-qyypPfizer Laboratories Div Pfizer IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83189SUPPL 2025-08-25
83169SUPPL 2025-08-22
62861SUPPL2020-05-08
61706SUPPL2020-01-28
58774ORIG2019-05-17
57963ORIG2019-03-12
57952ORIG2019-03-11