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FDA Approval

ACD-A

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

FDA Approval Summary

Company
Haemonetics Manufacturing Inc
DUNS: 078598396
Effective Date
February 9, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sodium citrate(2.20 g in 100 mL)
Glucose(2.45 g in 100 mL)
VS-01(0.73 g in 100 mL)

Registrants1

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

Haemonetics Manufacturing Inc

078598396

Manufacturing Establishments1

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

Haemonetics Manufacturing Inc

Haemonetics Manufacturing Inc

Haemonetics Manufacturing Inc

078598396

Products1

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
53157-796
Application Number
NDA710497
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
February 9, 2015
Sodium citrateActive
Code: 1Q73Q2JULRClass: ACTIBQuantity: 2.20 g in 100 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 2.45 g in 100 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.73 g in 100 mL
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