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Vegzelma

These highlights do not include all the information needed to use VEGZELMA safely and effectively. See full prescribing information for VEGZELMA. VEGZELMA (bevacizumab-adcd) injection, for intravenous use Initial U.S. Approval: 2022 VEGZELMA (bevacizumab-adcd) is biosimilar to AVASTIN (bevacizumab).

Approved
Approval ID

4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2023

Manufacturers
FDA

CELLTRION USA, Inc.

DUNS: 116587378

Products 2

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

bevacizumab-adcd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72606-012
Application NumberBLA761268
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-adcd
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2023
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-adcd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72606-011
Application NumberBLA761268
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-adcd
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 22, 2023
FDA Product Classification

INGREDIENTS (6)

BEVACIZUMABActive
Quantity: 100 mg in 4 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 240 mg in 4 mL
Code: 7YIN7J07X4
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 4.8 mg in 4 mL
Code: 22ADO53M6F
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 1.6 mg in 4 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 23.2 mg in 4 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Vegzelma - FDA Drug Approval Details