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FDA Approval

Sodium Citrate

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

FDA Approval Summary

Company
Effective Date
February 9, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sodium citrate(10.0 g in 250 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.

Sodium Citrate

Product Details

NDC Product Code
53157-798
Application Number
NDA760305
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
February 9, 2015
Code: 1Q73Q2JULRClass: ACTIBQuantity: 10.0 g in 250 mL
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