Details for New Drug Application (NDA): 019386

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NDA 019386 describes BREVIBLOC IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from five suppliers. Additional details are available on the BREVIBLOC IN PLASTIC CONTAINER profile page.

The generic ingredient in BREVIBLOC IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for 019386

Tradename:	BREVIBLOC IN PLASTIC CONTAINER
Applicant:	Baxter Hlthcare
Ingredient:	esmolol hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019386

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 019386

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386	NDA	Henry Schein, Inc	0404-9825	0404-9825-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9825-10) / 10 mL in 1 VIAL, SINGLE-DOSE
BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386	NDA	Baxter Healthcare Corporation	10019-055	10019-055-61	10 BAG in 1 CARTON (10019-055-61) / 250 mL in 1 BAG

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Aug 15, 1988	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/100ML
Approval Date:	Feb 16, 2001	TE:		RLD:	Yes

Profile for product number 005

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2GM/100ML
Approval Date:	Jan 27, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 019386

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	INJECTABLE;INJECTION	019386-005	Jan 27, 2003	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988	⤷ Try a Trial	⤷ Try a Trial
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386-003	Aug 15, 1988	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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