Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074067
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;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
11/05/1992 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/23/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/25/1996 SUPPL-11 Labeling

Label is not available on this site.

07/02/1996 SUPPL-10 Labeling

Label is not available on this site.

05/31/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/13/1995 SUPPL-8 Labeling

Label is not available on this site.

04/25/1995 SUPPL-7 Labeling

Label is not available on this site.

11/12/1993 SUPPL-6 Labeling

Label is not available on this site.

09/01/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/08/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/01/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/01/1993 SUPPL-2 Labeling

Label is not available on this site.

09/01/1993 SUPPL-1 Manufacturing (CMC)

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