Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Terumo BCT, Ltd.
Terumo BCT, Ltd.
233649834
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACD A
Product Details
NDC Product Code
14537-817Application Number
BA010228Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 31, 2017VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.8 g in 100 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 2.45 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 2.2 g in 100 mL
ACD A
Product Details
NDC Product Code
14537-815Application Number
BA010228Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 31, 2017VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.8 g in 100 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 2.45 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 2.2 g in 100 mL