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FDA NDA · NDA205703

ESMOLOL HYDROCHLORIDE IN WATER

esmolol hydrochloride

Sponsor: HQ SPCLT PHARMA

APPLICATION
NDA205703
TYPE
NDA
ORIGINAL APPROVAL
2016-04-07
LATEST ACTION
2024-05-02
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER · ReferencePrescription
ESMOLOL HYDROCHLORIDE 2GM/100ML (20MG/ML) · SOLUTION · INTRAVENOUS
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
ESMOLOL HYDROCHLORIDE 2.5GM/250ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-05-02Labeling · Supplement 3 · standard — Letter ↗AP
2016-04-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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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