← FDA DRUG APPROVALS

FDA ANDA · ANDA216603

ESMOLOL HYDROCHLORIDE

esmolol hydrochloride in sodium chloride

Sponsor: AMNEAL

APPLICATION
ANDA216603
TYPE
ANDA
ORIGINAL APPROVAL
2022-12-13
LATEST ACTION
2024-10-15
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

2024-10-15Labeling · Supplement 1 · standardAP
2024-10-15Labeling · Supplement 2 · standardAP
2022-12-13UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →