Product Details for ANDA 216439
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
120MG
Marketing Status: Prescription
180MG
Marketing Status: Prescription
240MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
360MG
Marketing Status: Prescription
420MG
Marketing Status: Prescription
120MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 001
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 001
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
180MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 002
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 002
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
240MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 003
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 003
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 004
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 004
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
360MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 360MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 005
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 360MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 005
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
420MG
Marketing Status: Prescription
Active Ingredient: DILTIAZEM HYDROCHLORIDE
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 420MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 006
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DILTIAZEM HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 420MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216439
Product Number: 006
Approval Date: Mar 7, 2023
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status: Prescription
Patent and Exclusivity Information