Argatroban

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

Company

DUNS: 001230762

Effective Date

October 20, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Argatroban(250 mg in 2.5 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

001230762

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

NDC Product Code

0143-9288

Application Number

NDA203049

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

October 20, 2020

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

Code: IY90U61Z3SClass: ACTIMQuantity: 250 mg in 2.5 mL