Product Details for NDA 020027
CARDIZEM (DILTIAZEM HYDROCHLORIDE)
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020027
Product Number: 001
Approval Date: Oct 24, 1991
Applicant Holder Full Name: BIOVAIL LABORATORIES INTERNATIONAL SRL
Marketing Status: Discontinued
Patent and Exclusivity Information
CARDIZEM (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020027
Product Number: 001
Approval Date: Oct 24, 1991
Applicant Holder Full Name: BIOVAIL LABORATORIES INTERNATIONAL SRL
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020027
Product Number: 003
Approval Date: Aug 18, 1995
Applicant Holder Full Name: BIOVAIL LABORATORIES INTERNATIONAL SRL
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020027
Product Number: 003
Approval Date: Aug 18, 1995
Applicant Holder Full Name: BIOVAIL LABORATORIES INTERNATIONAL SRL
Marketing Status: Discontinued
Patent and Exclusivity Information