Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211596
Company: EDENBRIDGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/18/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

DILTIAZEM HYDROCHLORIDE

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 90MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 211596 EDENBRIDGE PHARMS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 074185 TEVA

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