← FDA DRUG APPROVALS

FDA NDA · NDA019386

BREVIBLOC

esmolol hydrochloride

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA019386
TYPE
NDA
ORIGINAL APPROVAL
1986-12-31
LATEST ACTION
2025-09-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

BREVIBLOC · ReferencePrescription
ESMOLOL HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
BREVIBLOC IN PLASTIC CONTAINER · ReferencePrescription
ESMOLOL HYDROCHLORIDE 1GM/100ML · INJECTABLE · INJECTION
BREVIBLOCDiscontinued
ESMOLOL HYDROCHLORIDE 250MG/ML · INJECTABLE · INJECTION
BREVIBLOCDiscontinued
ESMOLOL HYDROCHLORIDE 20MG/ML · INJECTABLE · INJECTION
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER · ReferencePrescription
ESMOLOL HYDROCHLORIDE 2GM/100ML · INJECTABLE · INJECTION
BREVIBLOCDiscontinued
ESMOLOL HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-09-23Manufacturing (CMC) · Supplement 55 — Label ↗AP
2023-06-15Labeling · Supplement 53 · standard — Label ↗AP
2015-08-14Manufacturing (CMC) · Supplement 48 · priorityAP
2015-01-26Manufacturing (CMC) · Supplement 47 · priorityAP
2014-03-20Manufacturing (CMC) · Supplement 46 · priorityAP
2013-08-13Manufacturing (CMC) · Supplement 41 · priorityAP
2012-12-11Labeling · Supplement 43 · unknown — Label ↗AP
2007-11-06Labeling · Supplement 39 · standard — Letter ↗AP
2003-08-18Manufacturing (CMC) · Supplement 24 · priority — Letter ↗AP
2003-05-28Manufacturing (CMC) · Supplement 22 · priority — Review ↗AP
2003-02-25Manufacturing (CMC) · Supplement 21 · priority — Review ↗AP
2003-01-27Manufacturing (CMC) · Supplement 20 · priority — Letter ↗AP
2003-01-27Manufacturing (CMC) · Supplement 19 · priority — Letter ↗AP
2001-02-16Manufacturing (CMC) · Supplement 18 · priority — Review ↗AP
2001-01-26Manufacturing (CMC) · Supplement 17 · priority — Review ↗AP
2000-02-23Manufacturing (CMC) · Supplement 15 · priority — Review ↗AP
2000-01-19Labeling · Supplement 16 · standardAP
1995-10-04Labeling · Supplement 13 · standardAP
1994-01-13Manufacturing (CMC) · Supplement 12 · priority — Review ↗AP
1993-11-24Manufacturing (CMC) · Supplement 11 · priority — Review ↗AP
1993-07-01Labeling · Supplement 10 · standard — Review ↗AP
1992-12-18Efficacy · Supplement 3AP
1992-12-18Efficacy · Supplement 8AP
1991-10-21Labeling · Supplement 9 — Review ↗AP
1989-05-26Manufacturing (CMC) · Supplement 5 · priority — Review ↗AP
1989-05-11Labeling · Supplement 7 — Review ↗AP
1988-08-15Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP
1988-08-15Labeling · Supplement 6 — Review ↗AP
1988-08-15Manufacturing (CMC) · Supplement 4 · priority — Review ↗AP
1988-08-15Labeling · Supplement 2 — Review ↗AP
1986-12-31Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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