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FDA Approval

Brevibloc

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

FDA Approval Summary

Company
Henry Schein, Inc
DUNS: 012430880
Effective Date
October 12, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Esmolol(10 mg in 1 mL)

Products1

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

Brevibloc

Product Details

NDC Product Code
0404-9825
Application Number
NDA019386
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
February 18, 2022
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
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