Angiomax
These highlights do not include all the information needed to use ANGIOMAX safely and effectively. See full prescribing information for ANGIOMAX. ANGIOMAX (bivalirudin) for injection, for intravenous useInitial U.S. Approval: 2000
Approved
Approval ID
5f133813-f74e-4508-bc64-debbf104ff1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2019
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bivalirudin
PRODUCT DETAILS
NDC Product Code0781-3447
Application NumberNDA020873
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2019
Generic Namebivalirudin
INGREDIENTS (3)
BIVALIRUDINActive
Quantity: 250 mg in 1 1
Code: TN9BEX005G
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT