Product Details for ANDA 211596
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
30MG
Marketing Status: Discontinued
60MG
Marketing Status: Discontinued
90MG
Marketing Status: Discontinued
120MG
Marketing Status: Discontinued
30MG
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 001
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 001
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
60MG
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 002
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 002
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
90MG
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 003
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 003
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
120MG
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 004
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A211596
Product Number: 004
Approval Date: Nov 18, 2019
Applicant Holder Full Name: EDENBRIDGE PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information