Application 019386

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	BREVIBLOC	ESMOLOL HYDROCHLORIDE	INJECTABLE; INJECTION	250MG/ML	No	No
003	BREVIBLOC	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	No	No
004	BREVIBLOC IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	1GM/100ML	Yes	Yes
005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	2GM/100ML	Yes	Yes
006	BREVIBLOC	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	Yes	Yes
007	BREVIBLOC	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9825	Brevibloc	esmolol hydrochloride	Henry Schein, Inc	NDA	Current
0404-9825	Brevibloc	esmolol hydrochloride	Henry Schein, Inc	NDA	Current
0404-9825	Brevibloc	Brevibloc	Henry Schein, Inc	NDA	Current
0641-2965	Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	West Ward Pharmaceutical Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-055	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-075	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-115	Brevibloc	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-120	Esmolol Hydrochloride	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-120	Esmolol Hydrochloride	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-120	Esmolol Hydrochloride	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-120	Esmolol Hydrochloride	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-120	Esmolol Hydrochloride	Esmolol Hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-666	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-666	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-666	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-666	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-666	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-666	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-668	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-668	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-668	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-668	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-668	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-668	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-670	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-670	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-670	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-670	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-670	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-670	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-672	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-672	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-672	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-672	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-672	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
10019-672	BREVIBLOC	esmolol hydrochloride	Baxter Healthcare Corporation	NDA	Current
51662-1427	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1427	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-017	Esmolol	Esmolol	General Injectables & Vaccines, Inc	NDA	Current
52584-115	Brevibloc	Brevibloc	General Injectables & Vaccines	NDA	Current
52584-115	Brevibloc	Brevibloc	General Injectables & Vaccines	NDA	Current
52584-115	Brevibloc	Brevibloc	General Injectables & Vaccines	NDA	Current
52584-115	Brevibloc	Brevibloc	General Injectables & Vaccines	NDA	Current
55154-2888	Esmolol Hydrochloride	Esmolol Hydrochloride	Cardinal Health	NDA	Current
71872-7136	Esmolol Hydrochloride	Esmolol Hydrochloride	Medical Purchasing Solutions, LLC	NDA	Current
71872-7136	Esmolol Hydrochloride	Esmolol Hydrochloride	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84138	SUPPL	2025-11-12
84137	SUPPL	2025-11-12
74538	SUPPL	2023-06-16
74506	SUPPL	2023-06-16
17383	SUPPL	2012-12-13
11498	SUPPL	2012-12-13
20237	SUPPL	2008-02-19
20236	SUPPL	2008-02-19
20235	SUPPL	2008-02-19
20234	SUPPL	2008-02-19
40906	SUPPL	2007-12-06
40905	SUPPL	2007-12-06
40904	SUPPL	2007-12-06
40903	SUPPL	2007-12-06
20233	SUPPL	2007-12-06
20232	SUPPL	2007-12-06
17382	SUPPL	2007-11-08
33734	SUPPL	2007-11-07
40907	SUPPL	2007-09-14
20239	SUPPL	2007-09-14
20238	SUPPL	2007-09-14
40909	SUPPL	2007-07-06
40902	ORIG	2004-10-04
1312	SUPPL	2003-08-26
40908	SUPPL	2003-07-08
17381	SUPPL	2003-05-30
1311	SUPPL	2003-03-10
17380	SUPPL	2003-01-27
1310	SUPPL	2003-01-27

Application 019386

Related Records#

Application Products#

NDC Listings For This Application#

Documents#