Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 208783

Expand all

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: A208783
Product Number: 001
Approval Date: Jun 14, 2019
Applicant Holder Full Name: NOVAST LABORATORIES LTD
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: A208783
Product Number: 002
Approval Date: Jun 14, 2019
Applicant Holder Full Name: NOVAST LABORATORIES LTD
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: A208783
Product Number: 003
Approval Date: Jun 14, 2019
Applicant Holder Full Name: NOVAST LABORATORIES LTD
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: A208783
Product Number: 004
Approval Date: Jun 14, 2019
Applicant Holder Full Name: NOVAST LABORATORIES LTD
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: AB3
Application Number: A208783
Product Number: 005
Approval Date: Jun 14, 2019
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English