OGIVRI
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2017
Approved
Approval ID
6b7938e6-14c7-4a65-9605-967542ecfb8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
trastuzumab-dkst
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-991
Application NumberBLA761074
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab-dkst
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 8, 2021
FDA Product Classification
INGREDIENTS (5)
TRASTUZUMABActive
Quantity: 150 mg in 7.4 mL
Code: P188ANX8CK
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
trastuzumab-dkst
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-847
Application NumberBLA761074
Product Classification
M
Marketing Category
C73585
G
Generic Name
trastuzumab-dkst
Product Specifications
Effective DateFebruary 8, 2021
FDA Product Classification