Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019386

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BREVIBLOC (ESMOLOL HYDROCHLORIDE)
10MG/ML
Marketing Status: Prescription

Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: BREVIBLOC
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019386
Product Number: 006
Approval Date: Feb 25, 2003
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (ESMOLOL HYDROCHLORIDE)
2GM/100ML
Marketing Status: Prescription

Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019386
Product Number: 005
Approval Date: Jan 27, 2003
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

BREVIBLOC IN PLASTIC CONTAINER (ESMOLOL HYDROCHLORIDE)
1GM/100ML
Marketing Status: Prescription

Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: BREVIBLOC IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019386
Product Number: 004
Approval Date: Feb 16, 2001
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

BREVIBLOC (ESMOLOL HYDROCHLORIDE)
10MG/ML
Marketing Status: Discontinued

Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: BREVIBLOC
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019386
Product Number: 003
Approval Date: Aug 15, 1988
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

BREVIBLOC (ESMOLOL HYDROCHLORIDE)
20MG/ML
Marketing Status: Discontinued

Active Ingredient: ESMOLOL HYDROCHLORIDE
Proprietary Name: BREVIBLOC
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019386
Product Number: 007
Approval Date: May 28, 2003
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information