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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074984

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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: AB3
Application Number: A074984
Product Number: 001
Approval Date: Dec 20, 1999
Applicant Holder Full Name: PAR PHARMACEUTICAL 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: AB3
Application Number: A074984
Product Number: 002
Approval Date: Dec 20, 1999
Applicant Holder Full Name: PAR PHARMACEUTICAL 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: No
TE Code: AB3
Application Number: A074984
Product Number: 003
Approval Date: Dec 20, 1999
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
300MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB3
Application Number: A074984
Product Number: 004
Approval Date: Dec 20, 1999
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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