Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074943

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DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
120MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A074943
Product Number: 003
Approval Date: Dec 19, 2000
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
180MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A074943
Product Number: 002
Approval Date: Dec 19, 2000
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
240MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB2
Application Number: A074943
Product Number: 001
Approval Date: Aug 6, 1998
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information