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FDA Approval

OGIVRI

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 8, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trastuzumab(150 mg in 7.4 mL)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

OGIVRI

Product Details

NDC Product Code
67457-991
Application Number
BLA761074
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS
Effective Date
February 8, 2021
Code: P188ANX8CKClass: ACTIBQuantity: 150 mg in 7.4 mL
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6Class: IACT
HISTIDINEInactive
Code: 4QD397987EClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT

OGIVRI

Product Details

NDC Product Code
67457-847
Application Number
BLA761074
Marketing Category
BLA (C73585)
Effective Date
February 8, 2021
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