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FDA Approval

Esmolol Hydrochloride

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

FDA Approval Summary

Company
WG Critical Care, LLC
DUNS: 829274633
Effective Date
August 23, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Esmolol(20 mg in 1 mL)

Products2

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

Esmolol Hydrochloride

Product Details

NDC Product Code
44567-451
Application Number
ANDA214172
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 23, 2023
natural latex rubberInactive
Code: 2LQ0UUW8INClass: CNTMQuantity: 0 1 in 1 mL
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 20 mg in 1 mL

Esmolol Hydrochloride

Product Details

NDC Product Code
44567-450
Application Number
ANDA214172
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 23, 2023
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
natural latex rubberInactive
Code: 2LQ0UUW8INClass: CNTMQuantity: 0 1 in 1 mL
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