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FDA Approval

Additive Formula 3

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

FDA Approval Summary

Company
Terumo BCT, Ltd
DUNS: 233649834
Effective Date
December 15, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sodium chloride(0.41 g in 100 mL)
VS-01(0.042 g in 100 mL)
Adenine(0.03 g in 100 mL)
Glucose(1.1 g in 100 mL)
Sodium phosphate, dibasic(0.28 g in 100 mL)
Gadofosveset trisodium(0.59 g in 100 mL)

Registrants1

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

Terumo BCT, Inc.

801679200

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

Terumo BCT, Inc.

233649834

Products3

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

Additive Formula 3

Product Details

NDC Product Code
14537-833
Application Number
BN001214
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
December 15, 2021
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 0.41 g in 100 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.042 g in 100 mL
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.03 g in 100 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.1 g in 100 mL
Sodium phosphate, dibasicActive
Code: 593YOG76RNClass: ACTIBQuantity: 0.28 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 0.59 g in 100 mL

Additive Formula 3

Product Details

NDC Product Code
14537-834
Application Number
BN001214
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
December 15, 2021
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.1 g in 100 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 0.41 g in 100 mL
Sodium phosphate, dibasicActive
Code: 593YOG76RNClass: ACTIBQuantity: 0.28 g in 100 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.042 g in 100 mL
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.03 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 0.59 g in 100 mL

Additive Formula 3

Product Details

NDC Product Code
14537-832
Application Number
BN001214
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
December 15, 2021
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 0.41 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.1 g in 100 mL
Sodium phosphate, dibasicActive
Code: 593YOG76RNClass: ACTIBQuantity: 0.28 g in 100 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.042 g in 100 mL
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.03 g in 100 mL
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 0.59 g in 100 mL
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