Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076151
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILT-CD DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILT-CD DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILT-CD DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILT-CD DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None 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
05/20/2004 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076151_s000_DiltTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/22/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

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