CPDA-1

CPDA-1

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

FDA Approval Summary

Company

Fenwal, Inc.

DUNS: 794519020

Effective Date

August 27, 2014

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Gadofosveset trisodium(1.84 g in 70 mL)

Glucose(2.23 g in 70 mL)

Sodium phosphate, dibasic(155 mg in 70 mL)

Citric acid(209 mg in 70 mL)

Adenine(19.3 mg in 70 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Fenwal International, Inc.

Labeler

Fenwal, Inc.

DUNS Number

091164590

Products1

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

Product Details

NDC Product Code

0942-6326

Application Number

BN770420

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

August 27, 2014

Ingredients

Gadofosveset trisodiumActive

Code: B22547B95KClass: ACTIMQuantity: 1.84 g in 70 mL

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 2.23 g in 70 mL

Sodium phosphate, dibasicActive

Code: 593YOG76RNClass: ACTIBQuantity: 155 mg in 70 mL

Citric acidActive

Code: XF417D3PSLClass: ACTIBQuantity: 209 mg in 70 mL

AdenineActive

Code: JAC85A2161Class: ACTIBQuantity: 19.3 mg in 70 mL

Sodium HydroxideInactive

Code: 55X04QC32IClass: IACT

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CPDA-1

FDA Approval Summary

Manufacturing Establishments1

Products1

CPDA-1

Product Details