Argatroban

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

Company

DUNS: 796852890

Effective Date

March 3, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Argatroban(1 mg in 1 mL)

Products1

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

NDC Product Code

25021-414

Application Number

ANDA214235

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

March 3, 2021

Ingredients

AlcoholInactive

Code: 3K9958V90MClass: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Code: IY90U61Z3SClass: ACTIMQuantity: 1 mg in 1 mL

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACT