Argatroban
These highlights do not include all the information needed to use ARGATROBAN INJECTION safely and effectively. See full prescribing information for ARGATROBAN INJECTION. ARGATROBAN injection, for intravenous infusion onlyInitial U.S. Approval: 2000
Approved
Approval ID
b0dedf95-8395-46bf-b94a-dcf2dd085942
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
argatroban
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-212
Application NumberANDA202626
Product Classification
M
Marketing Category
C73584
G
Generic Name
argatroban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 29, 2017
FDA Product Classification
INGREDIENTS (4)
ARGATROBANActive
Quantity: 250 mg in 2.5 mL
Code: IY90U61Z3S
Classification: ACTIM
SORBITOLInactive
Quantity: 750 mg in 2.5 mL
Code: 506T60A25R
Classification: IACT
ALCOHOLInactive
Quantity: 1000 mg in 2.5 mL
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT