Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Caplin Steriles Limited
Fresenius Kabi USA, LLC
650744670
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Argatroban
Product Details
NDC Product Code
65219-429Application Number
ANDA214235Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
March 1, 2021AlcoholInactive
Code: 3K9958V90MClass: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
ArgatrobanActive
Code: IY90U61Z3SClass: ACTIMQuantity: 50 mg in 50 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT