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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019471

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CARDIZEM SR (DILTIAZEM HYDROCHLORIDE)
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019471
Product Number: 001
Approval Date: Jan 23, 1989
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARDIZEM SR (DILTIAZEM HYDROCHLORIDE)
90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019471
Product Number: 002
Approval Date: Jan 23, 1989
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARDIZEM SR (DILTIAZEM HYDROCHLORIDE)
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019471
Product Number: 003
Approval Date: Jan 23, 1989
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
CARDIZEM SR (DILTIAZEM HYDROCHLORIDE)
180MG **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 SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 180MG **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: N019471
Product Number: 004
Approval Date: Jan 23, 1989
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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