Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017924
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGAMET CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued None No No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
08/16/1977 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/15/1997 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-58 Labeling

Label is not available on this site.

11/10/1993 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1992 SUPPL-53 Labeling

Label is not available on this site.

08/27/1992 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1991 SUPPL-50 Labeling

Label is not available on this site.

11/13/1989 SUPPL-49 Labeling

Label is not available on this site.

05/30/1990 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1991 SUPPL-46 Labeling

Label is not available on this site.

06/26/1989 SUPPL-45 Labeling

Label is not available on this site.

06/26/1989 SUPPL-44 Labeling

Label is not available on this site.

06/15/1988 SUPPL-42 Labeling

Label is not available on this site.

05/20/1988 SUPPL-41 Labeling

Label is not available on this site.

03/31/1988 SUPPL-40 Efficacy-New Dosing Regimen

Label is not available on this site.

04/23/1986 SUPPL-38 Labeling

Label is not available on this site.

01/13/1986 SUPPL-37 Labeling

Label is not available on this site.

05/15/1985 SUPPL-36 Labeling

Label is not available on this site.

04/18/1985 SUPPL-35 Labeling

Label is not available on this site.

02/07/1985 SUPPL-34 Labeling

Label is not available on this site.

04/29/1986 SUPPL-33 Efficacy-New Dosing Regimen

Label is not available on this site.

06/14/1984 SUPPL-32 Labeling

Label is not available on this site.

07/19/1984 SUPPL-31 Labeling

Label is not available on this site.

12/05/1984 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/1984 SUPPL-29 Labeling

Label is not available on this site.

07/19/1984 SUPPL-27 Labeling

Label is not available on this site.

02/28/1983 SUPPL-25 Labeling

Label is not available on this site.

01/31/1983 SUPPL-24 Efficacy

Label is not available on this site.

03/11/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/25/1982 SUPPL-22 Efficacy

Label is not available on this site.

01/22/1982 SUPPL-19 Labeling

Label is not available on this site.

12/30/1982 SUPPL-18 Labeling

Label is not available on this site.

11/02/1981 SUPPL-17 Labeling

Label is not available on this site.

07/13/1981 SUPPL-16 Labeling

Label is not available on this site.

06/12/1981 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/22/1981 SUPPL-13 Labeling

Label is not available on this site.

01/22/1981 SUPPL-12 Labeling

Label is not available on this site.

12/30/1982 SUPPL-11 Efficacy

Label is not available on this site.

07/08/1980 SUPPL-10 Labeling

Label is not available on this site.

01/08/1980 SUPPL-8 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