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FDA ANDA · ANDA205520

ESMOLOL HYDROCHLORIDE

Sponsor: EUGIA PHARMA

APPLICATION
ANDA205520
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-23
LATEST ACTION
2024-07-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ESMOLOL HYDROCHLORIDEPrescription
ESMOLOL HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2024-07-09Labeling · Supplement 7 · standardAP
2015-07-23UNKNOWN · Original · standardLetterAP
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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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