Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Caplin Steriles Limited
Caplin Steriles Limited
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
65145-126Application Number
ANDA214235Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
February 1, 2021SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ArgatrobanActive
Code: IY90U61Z3SClass: ACTIMQuantity: 50 mg in 50 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT