Trazimera
These highlights do not include all the information needed to use TRAZIMERA safely and effectively. See full prescribing information for TRAZIMERA. TRAZIMERA™ (trastuzumab-qyyp) for injection, for intravenous use Initial U.S. Approval: 2019 TRAZIMERA (trastuzumab-qyyp) is biosimilar to HERCEPTIN (trastuzumab).
Approved
Approval ID
b9c5e894-27d2-4245-a653-df986fed3c56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2022
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
trastuzumab-qyyp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0305
Application NumberBLA761081
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab-qyyp
Product Specifications
Effective DateFebruary 14, 2022
FDA Product Classification
trastuzumab-qyyp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0308
Application NumberBLA761081
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab-qyyp
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 14, 2022
FDA Product Classification
INGREDIENTS (5)
TRASTUZUMABActive
Quantity: 150 mg in 7.15 mL
Code: P188ANX8CK
Classification: ACTIB
HISTIDINEInactive
Quantity: 2.8 mg in 7.15 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 3.4 mg in 7.15 mL
Code: X573657P6P
Classification: IACT
SUCROSEInactive
Quantity: 138 mg in 7.15 mL
Code: C151H8M554
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.6 mg in 7.15 mL
Code: 7T1F30V5YH
Classification: IACT