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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

Tradename:
BREVIBLOC
Applicant:
Baxter Hlthcare
Ingredient:
esmolol hydrochloride
Patents:2
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
BREVIBLOC
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)
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

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
BREVIBLOC
esmolol hydrochloride
INJECTABLE;INJECTION019386-003Aug 15, 19884,387,103► subscribe
Baxter Hlthcare
BREVIBLOC IN PLASTIC CONTAINER
esmolol hydrochloride
INJECTABLE;INJECTION019386-004Feb 16, 20014,593,119*PED► subscribe
Baxter Hlthcare
BREVIBLOC
esmolol hydrochloride
INJECTABLE;INJECTION019386-006Feb 25, 20034,593,119*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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