Argatroban

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

Company

DUNS: 790384502

Effective Date

April 14, 2021

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

67457-212

Application Number

ANDA202626

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

August 29, 2017

Ingredients

Code: IY90U61Z3SClass: ACTIMQuantity: 250 mg in 2.5 mL

SORBITOLInactive

Code: 506T60A25RClass: IACTQuantity: 750 mg in 2.5 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACTQuantity: 1000 mg in 2.5 mL

WATERInactive

Code: 059QF0KO0RClass: IACT