Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019434
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIMETIDINE HYDROCHLORIDE EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
10/31/1985 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
01/08/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/15/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-27 Labeling

Label is not available on this site.

11/10/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/13/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/23/1996 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1992 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1992 SUPPL-19 Labeling

Label is not available on this site.

08/27/1992 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1991 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1991 SUPPL-14 Labeling

Label is not available on this site.

11/13/1989 SUPPL-13 Labeling

Label is not available on this site.

05/30/1990 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1991 SUPPL-10 Labeling

Label is not available on this site.

06/26/1989 SUPPL-9 Labeling

Label is not available on this site.

03/20/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/26/1989 SUPPL-7 Labeling

Label is not available on this site.

06/15/1988 SUPPL-5 Labeling

Label is not available on this site.

05/20/1988 SUPPL-4 Labeling

Label is not available on this site.

03/31/1988 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

04/29/1986 SUPPL-2 Labeling

Label is not available on this site.

04/23/1986 SUPPL-1 Labeling

Label is not available on this site.

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