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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
Effective Date
September 12, 2019
Labeling Type
Human Prescription Drug Label
Esmolol(100 mg in 10 mL)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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
50090-4512
Application Number
ANDA205520
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 17, 2017
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 100 mg in 10 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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