Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206641

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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: AB4
Application Number: A206641
Product Number: 001
Approval Date: Aug 11, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA 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: AB4
Application Number: A206641
Product Number: 002
Approval Date: Aug 11, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA 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: AB4
Application Number: A206641
Product Number: 003
Approval Date: Aug 11, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA 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: AB4
Application Number: A206641
Product Number: 004
Approval Date: Aug 11, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
360MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 360MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB4
Application Number: A206641
Product Number: 005
Approval Date: Aug 11, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
420MG
Marketing Status: Prescription

Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 420MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB4
Application Number: A206641
Product Number: 006
Approval Date: Aug 11, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information