Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019471
Company: BIOVAIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIZEM SR DILTIAZEM HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
CARDIZEM SR DILTIAZEM HYDROCHLORIDE 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
CARDIZEM SR DILTIAZEM HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
CARDIZEM SR DILTIAZEM HYDROCHLORIDE 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No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
01/23/1989 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/21/2003 SUPPL-29 Labeling

Label is not available on this site.

12/03/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/20/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1997 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1996 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1996 SUPPL-24 Labeling

Label is not available on this site.

03/17/1995 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1994 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/03/1995 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1994 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-15 Labeling

Label is not available on this site.

10/22/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1992 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1991 SUPPL-11 Labeling

Label is not available on this site.

07/01/1992 SUPPL-10 Labeling

Label is not available on this site.

01/07/1991 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1990 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/27/1990 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/16/1990 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1990 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1989 SUPPL-1 Manufacturing (CMC)-Control

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