ALYMSYS
ALYMSYS (bevacizumab-maly) is biosimilar* to AVASTIN (bevacizumab)
Approved
Approval ID
6b4040a2-a5c5-4ff0-ab45-935d7e49cf78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bevacizumab-maly
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1755
Application NumberBLA761231
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-maly
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 23, 2022
FDA Product Classification
INGREDIENTS (6)
TREHALOSE DIHYDRATEInactive
Quantity: 960 mg in 16 mL
Code: 7YIN7J07X4
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 6.4 mg in 16 mL
Code: 7T1F30V5YH
Classification: IACT
BEVACIZUMABActive
Quantity: 400 mg in 16 mL
Code: 2S9ZZM9Q9V
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 19.2 mg in 16 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 92.8 mg in 16 mL
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bevacizumab-maly
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1754
Application NumberBLA761231
Product Classification
M
Marketing Category
C73585
G
Generic Name
bevacizumab-maly
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 23, 2022
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
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