Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019008

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BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BRETYLIUM TOSYLATE)
200MG/100ML
Marketing Status: Discontinued

Active Ingredient: BRETYLIUM TOSYLATE
Proprietary Name: BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019008
Product Number: 002
Approval Date: Apr 29, 1986
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BRETYLIUM TOSYLATE)
400MG/100ML
Marketing Status: Discontinued

Active Ingredient: BRETYLIUM TOSYLATE
Proprietary Name: BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 400MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019008
Product Number: 003
Approval Date: Apr 29, 1986
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BRETYLIUM TOSYLATE)
800MG/100ML
Marketing Status: Discontinued

Active Ingredient: BRETYLIUM TOSYLATE
Proprietary Name: BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 800MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019008
Product Number: 001
Approval Date: Apr 29, 1986
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information