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Last Updated: May 18, 2024

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 four 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. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
Summary for 019386
Applicant:Baxter Hlthcare
Ingredient:esmolol hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 019386
Mechanism of ActionAdrenergic 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:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Aug 15, 1988TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/100ML
Approval Date:Feb 16, 2001TE:APRLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/100ML
Approval Date:Jan 27, 2003TE:APRLD:Yes

Expired US Patents for NDA 019386

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