Argatroban

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 092733690

Effective Date

December 31, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Argatroban(250 mg in 2.5 mL)

Products1

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

NDC Product Code

42023-182

Application Number

ANDA091665

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

February 9, 2023

Ingredients

Code: IY90U61Z3SClass: ACTIMQuantity: 250 mg in 2.5 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT