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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021392

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CARDIZEM LA (DILTIAZEM HYDROCHLORIDE)
120MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM LA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021392
Product Number: 001
Approval Date: Feb 6, 2003
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDIZEM LA (DILTIAZEM HYDROCHLORIDE)
180MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM LA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021392
Product Number: 002
Approval Date: Feb 6, 2003
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDIZEM LA (DILTIAZEM HYDROCHLORIDE)
240MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM LA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021392
Product Number: 003
Approval Date: Feb 6, 2003
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDIZEM LA (DILTIAZEM HYDROCHLORIDE)
300MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM LA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021392
Product Number: 004
Approval Date: Feb 6, 2003
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDIZEM LA (DILTIAZEM HYDROCHLORIDE)
360MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM LA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 360MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021392
Product Number: 005
Approval Date: Feb 6, 2003
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CARDIZEM LA (DILTIAZEM HYDROCHLORIDE)
420MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: CARDIZEM LA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 420MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021392
Product Number: 006
Approval Date: Feb 6, 2003
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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