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FDA ANDA · ANDA206608
ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE
Sponsor: MYLAN LABS LTD
APPLICATION
ANDA206608
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-08
LATEST ACTION
2024-03-19
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
2024-03-19Labeling · Supplement 12 · 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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