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FDA ANDA · ANDA076474

ESMOLOL HYDROCHLORIDE

Sponsor: MYLAN INSTITUTIONAL

APPLICATION
ANDA076474
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-02
LATEST ACTION
2024-11-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2024-11-07Labeling · Supplement 12 · standardAP
2024-11-07Labeling · Supplement 15 · standardAP
2010-07-29Labeling · Supplement 6AP
2005-05-02OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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