esmolol Injectable Solution

Brand(s)
Brevibloc
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2014-04-01)
Oldest Current Product
1986-12-31
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\ESMOLOL
FDAOB
INJECTION\INJECTION\ESMOLOL HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ESMOLOL HYDROCHLORIDE
INTRAVENOUS\INJECTION\ESMOLOL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ESMOLOL
INTRAVENOUS\INJECTION\ESMOLOL

product(s) by strength(s)

esmolol hydrochloride 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006412965NDAWest-Ward Pharmaceuticals Corp.1986-12-31ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTIONNDA019386a70baf53-e38a-4b23-8905-ee284170236d
2100190055BreviblocNDABaxter Healthcare Corporation1986-12-31ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTIONNDA019386595cc3d5-1306-4828-aefa-5595219ffd62

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551500194ANDAAuromedics Pharma Llc2015-07-23ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA205520ac22475d-2d78-469f-9435-b403ac4ee380
2633230652ANDAApp Pharmaceuticals, Llc2004-11-30ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA076573fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2
3674570182ANDAMylan Institutional Llc2013-02-21ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA07647494f069f9-dd52-4a69-a103-ebdb4294f088

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840017NDAGeneral Injecatables & Vaccines, Inc2010-04-01ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION006412965NDA01938635460df2-18d3-4132-85e6-5289bad4c670
2525840049ANDAGeneral Injecatables & Vaccines, Inc2015-09-10ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION674570182ANDA076474a2e031a3-10ab-40e5-a421-eb54d00c0ac5
3525840062ANDAGeneral Injecatables & Vaccines, Inc2010-08-01ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION553900062ANDA076323f1a60c72-a4e3-437d-b472-8d5bffc91273
4525840115NDAGeneral Injecatables & Vaccines, Inc2010-07-01ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION100190115NDA019386c8d2e135-ec31-4eee-bce2-c85e7858c5e1
5525840652ANDAGeneral Injecatables & Vaccines, Inc2012-06-13ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION633230652ANDA076573b0df082a-838f-4556-8399-dd8229c5974a
6551542888NDACardinal Health1986-12-31ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTION100190120NDA0193866dcbdd78-c69d-4d70-81ce-8cb7f7580b48

esmolol hydrochloride 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1100190075BreviblocNDABaxter Healthcare Corporation1986-12-31ESMOLOL HYDROCHLORIDEINTRAVENOUSINJECTIONNDA019386595cc3d5-1306-4828-aefa-5595219ffd62

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076323ESMOLOL HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2004-08-10ANDA076323_001
2ANDA076474ESMOLOL HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2005-05-02ANDA076474_001
3ANDA076573ESMOLOL HYDROCHLORIDEFRESENIUS KABI USA LLC2005-05-02ANDA076573_001
4ANDA201126ESMOLOL HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2015-02-20ANDA201126_001
5ANDA205520ESMOLOL HYDROCHLORIDEAUROBINDO PHARMA LTD2015-07-23ANDA205520_001
6NDA019386BREVIBLOCBAXTER HEALTHCARE CORP1988-08-15p6310094
p6528540
NDA019386_003, NDA019386_004, NDA019386_005, NDA019386_006, NDA019386_007

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076323_001RXESMOLOL HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2004-08-10ESMOLOL HYDROCHLORIDE
2ANDA076474_001RXESMOLOL HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2005-05-02ESMOLOL HYDROCHLORIDE
3ANDA076573_001RXESMOLOL HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2005-05-02ESMOLOL HYDROCHLORIDE
4ANDA201126_001RXESMOLOL HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2015-02-20ESMOLOL HYDROCHLORIDE
5ANDA205520_001RXESMOLOL HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2015-07-23ESMOLOL HYDROCHLORIDE
6NDA019386_003discontinuedESMOLOL HYDROCHLORIDE (10MG/ML)INJECTIONFalse1988-08-15BREVIBLOC
7NDA019386_004RXESMOLOL HYDROCHLORIDE (1GM/100ML)INJECTIONTrue2001-02-16BREVIBLOC
8NDA019386_005RXESMOLOL HYDROCHLORIDE (2GM/100ML)INJECTIONTrue2003-01-27BREVIBLOC
9NDA019386_006RXESMOLOL HYDROCHLORIDE (10MG/ML)INJECTIONTrueAP2003-02-25BREVIBLOC
10NDA019386_007discontinuedESMOLOL HYDROCHLORIDE (20MG/ML)INJECTIONFalse2003-05-28BREVIBLOC

patent(s)

#idexpiration dateapplication(s)
1p6310094 (view patent)2021-01-12NDA019386
2p6528540 (view patent)2021-01-12NDA019386

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
135460df2-18d3-4132-85e6-5289bad4c670 (view SPL)Esmolol HCL 10 mg/mL Injection 10mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-262525840017
2595cc3d5-1306-4828-aefa-5595219ffd62 (view SPL)These highlights do not include all the information needed to use BREVIBLOC safely and effectively. See full prescribing information for BREVIBLOC injection.BREVIBLOC (Esmolol Hydrochloride) injection, for intravenous use Initial U.S. Approval: 1986prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-04-017100190055, 100190075, 100190115
36dcbdd78-c69d-4d70-81ce-8cb7f7580b48 (view SPL)These highlights do not include all the information needed to use Esmolol Hydrochloride safely and effectively. See full prescribing information for Esmolol Hydrochloride injection. Esmolol Hydrochloride injection, for intravenous use Initial U.S. Approval: 1986prescriptionHuman PrescriptionCardinal HealthREPACK2015-09-242551542888
494f069f9-dd52-4a69-a103-ebdb4294f088 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2012-04-304674570182
5a2e031a3-10ab-40e5-a421-eb54d00c0ac5 (view SPL)ESMOLOL HYDROCHLORIDEprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2015-09-101525840049
6a70baf53-e38a-4b23-8905-ee284170236d (view SPL)Esmolol Hydrochloride InjectionprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2007-11-062006412965
7ac22475d-2d78-469f-9435-b403ac4ee380 (view SPL)These highlights do not include all the information needed to use ESMOLOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ESMOLOL HYDROCHLORIDE INJECTION. ESMOLOL HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1986prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, MANUFACTURE2015-07-271551500194
8b0df082a-838f-4556-8399-dd8229c5974a (view SPL)Esmolol Hydrochloride Injection (10 mg/mL) For Intravenous Use 10 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2015-09-082525840652
9c8d2e135-ec31-4eee-bce2-c85e7858c5e1 (view SPL)Brevibloc (Esmolol Hydrochloride) 10 mg/mL Injection 10 mL Single Dose VialThese highlights do not include all the information needed to use BREVIBLOC safely and effectively. See full prescribing information for BREVIBLOC injection.BREVIBLOC (Esmolol Hydrochloride) injection, for intravenous use Initial U.S. Approval: 1986prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-03-183525840115
10f0a56c07-8f0f-4499-8d00-f13a966bf988 (view SPL)These highlights do not include all the information needed to use Esmolol Hydrochloride safely and effectively. See full prescribing information for Esmolol Hydrochloride injection. Esmolol Hydrochloride injection, for intravenous use Initial U.S. Approval: 1986prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-04-013100190120
11f1a60c72-a4e3-437d-b472-8d5bffc91273 (view SPL)Esmolol HCL Injection 10 mg/mL Injection, USP 10 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-03-242525840062
12fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2 (view SPL)These highlights do not include all the information needed to use Esmolol Hydrochloride Injection safely and effectively. See full prescribing information for Esmolol Hydrochloride Injection. Esmolol Hydrochloride Injection, for intravenous use Initial U.S. Approval: 1986prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-05-162633230652

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII