Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215775

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DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
60MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A215775
Product Number: 001
Approval Date: May 5, 2022
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
90MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A215775
Product Number: 002
Approval Date: May 5, 2022
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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: AB1
Application Number: A215775
Product Number: 003
Approval Date: May 5, 2022
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information