Product Details for NDA 019121
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BRETYLIUM TOSYLATE)
100MG/100ML
Marketing Status: Discontinued
200MG/100ML
Marketing Status: Discontinued
400MG/100ML
Marketing Status: Discontinued
100MG/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: 100MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019121
Product Number: 001
Approval Date: Apr 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (BRETYLIUM TOSYLATE)
Proprietary Name: BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019121
Product Number: 001
Approval Date: Apr 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
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: N019121
Product Number: 002
Approval Date: Apr 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER (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: N019121
Product Number: 002
Approval Date: Apr 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
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: N019121
Product Number: 003
Approval Date: Apr 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
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: N019121
Product Number: 003
Approval Date: Apr 29, 1986
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information