APPLICATION
ANDA207107
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-08
LATEST ACTION
2025-10-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ESMOLOL HYDROCHLORIDEPrescription
ESMOLOL HYDROCHLORIDE 1GM/100ML · INJECTABLE · INJECTION
ESMOLOL HYDROCHLORIDEPrescription
ESMOLOL HYDROCHLORIDE 2GM/100ML · INJECTABLE · INJECTION
Approval history
2025-10-22Labeling · Supplement 4 · standardAP
2018-06-08UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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