Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020401

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TIAZAC (DILTIAZEM HYDROCHLORIDE)
120MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: TIAZAC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB4
Application Number: N020401
Product Number: 001
Approval Date: Sep 11, 1995
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

TIAZAC (DILTIAZEM HYDROCHLORIDE)
180MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: TIAZAC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB4
Application Number: N020401
Product Number: 002
Approval Date: Sep 11, 1995
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

TIAZAC (DILTIAZEM HYDROCHLORIDE)
240MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: TIAZAC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB4
Application Number: N020401
Product Number: 003
Approval Date: Sep 11, 1995
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

TIAZAC (DILTIAZEM HYDROCHLORIDE)
300MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: TIAZAC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB4
Application Number: N020401
Product Number: 004
Approval Date: Sep 11, 1995
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

TIAZAC (DILTIAZEM HYDROCHLORIDE)
360MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: TIAZAC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 360MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB4
Application Number: N020401
Product Number: 005
Approval Date: Sep 11, 1995
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

TIAZAC (DILTIAZEM HYDROCHLORIDE)
420MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: TIAZAC
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 420MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB4
Application Number: N020401
Product Number: 006
Approval Date: Oct 16, 1998
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information