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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. There are two patents protecting this drug. 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. Ten suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esmolol hydrochloride profile page.

Summary for NDA: 019386

Baxter Hlthcare
esmolol hydrochloride
Therapeutic Class:Cardiovascular Agents
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
esmolol hydrochloride
INJECTABLE;INJECTION 019386 NDA West Ward Pharmaceutical Corporation 0641-2965 0641-2965-45 25 VIAL in 1 BOX (0641-2965-45) > 10 mL in 1 VIAL (0641-2965-41)
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

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Aug 15, 1988TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/100ML
Approval Date:Feb 16, 2001TE:RLD:Yes
Patent:6,310,094*PEDPatent Expiration:Jul 12, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:6,528,540*PEDPatent Expiration:Jul 12, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 019386

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare
esmolol hydrochloride
INJECTABLE;INJECTION019386-003Aug 15, 19884,387,103► subscribe
Baxter Hlthcare
esmolol hydrochloride
INJECTABLE;INJECTION019386-004Feb 16, 20014,593,119*PED► subscribe
Baxter Hlthcare
esmolol hydrochloride
INJECTABLE;INJECTION019386-006Feb 25, 20034,593,119*PED► subscribe
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