MVASI
These highlights do not include all the information needed to use MVASI safely and effectively. See full prescribing information for MVASI. MVASI (bevacizumab-awwb) injection, for intravenous use Initial U.S. Approval: 2017 MVASI (bevacizumab-awwb) is biosimilar to AVASTIN (bevacizumab)
Approved
Approval ID
0a562b4e-67ce-4bab-852c-d9ee71e55fb8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2021
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bevacizumab-awwb
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-207
Application NumberBLA761028
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-awwb
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2021
FDA Product Classification
INGREDIENTS (6)
BEVACIZUMABActive
Quantity: 400 mg in 16 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 960 mg in 16 mL
Code: 7YIN7J07X4
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 19.2 mg in 16 mL
Code: 22ADO53M6F
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 6.4 mg in 16 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 92.8 mg in 16 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bevacizumab-awwb
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-206
Application NumberBLA761028
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-awwb
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2021
FDA Product Classification
INGREDIENTS (6)
BEVACIZUMABActive
Quantity: 100 mg in 4 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB
POLYSORBATE 20Inactive
Quantity: 1.6 mg in 4 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 4.8 mg in 4 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 23.2 mg in 4 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 240 mg in 4 mL
Code: 7YIN7J07X4
Classification: IACT
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 2/17/2023
RECENT MAJOR CHANGES
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Warnings and Precautions, Infusion Related Reactions (5.9) |
02/2023 |