Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018602

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CARDIZEM (DILTIAZEM HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018602
Product Number: 001
Approval Date: Nov 5, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARDIZEM (DILTIAZEM HYDROCHLORIDE)
60MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018602
Product Number: 002
Approval Date: Nov 5, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARDIZEM (DILTIAZEM HYDROCHLORIDE)
90MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018602
Product Number: 003
Approval Date: Dec 8, 1986
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARDIZEM (DILTIAZEM HYDROCHLORIDE)
120MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018602
Product Number: 004
Approval Date: Dec 8, 1986
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information