Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017939
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGAMET CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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 3 - New Dosage Form 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-86 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-85 Labeling

Label is not available on this site.

11/10/1993 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1992 SUPPL-80 Labeling

Label is not available on this site.

08/27/1992 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1991 SUPPL-77 Efficacy-New Indication

Label is not available on this site.

03/21/1990 SUPPL-76 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/1990 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1991 SUPPL-73 Labeling

Label is not available on this site.

06/26/1989 SUPPL-72 Labeling

Label is not available on this site.

03/20/1989 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

06/26/1989 SUPPL-70 Labeling

Label is not available on this site.

06/15/1988 SUPPL-68 Labeling

Label is not available on this site.

05/20/1988 SUPPL-67 Labeling

Label is not available on this site.

11/13/1989 SUPPL-66 Efficacy-New Dosing Regimen

Label is not available on this site.

06/03/1987 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-64 Efficacy-New Dosing Regimen

Label is not available on this site.

07/24/1986 SUPPL-63 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/23/1986 SUPPL-61 Labeling

Label is not available on this site.

01/13/1986 SUPPL-59 Labeling

Label is not available on this site.

05/15/1985 SUPPL-58 Labeling

Label is not available on this site.

04/18/1985 SUPPL-57 Labeling

Label is not available on this site.

02/07/1985 SUPPL-56 Labeling

Label is not available on this site.

04/29/1986 SUPPL-55 Efficacy-New Dosing Regimen

Label is not available on this site.

01/23/1985 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1984 SUPPL-53 Labeling

Label is not available on this site.

07/19/1984 SUPPL-52 Labeling

Label is not available on this site.

07/11/1984 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/1984 SUPPL-50 Labeling

Label is not available on this site.

03/05/1984 SUPPL-49 Labeling

Label is not available on this site.

11/29/1983 SUPPL-47 Labeling

Label is not available on this site.

07/19/1984 SUPPL-45 Labeling

Label is not available on this site.

02/28/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/28/1983 SUPPL-42 Labeling

Label is not available on this site.

01/31/1983 SUPPL-41 Efficacy

Label is not available on this site.

04/22/1983 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/20/1985 SUPPL-39 Efficacy-New Indication

Label is not available on this site.

08/25/1982 SUPPL-38 Efficacy

Label is not available on this site.

02/04/1982 SUPPL-36 Labeling

Label is not available on this site.

01/22/1982 SUPPL-34 Labeling

Label is not available on this site.

12/03/1981 SUPPL-33 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/30/1982 SUPPL-32 Labeling

Label is not available on this site.

11/02/1981 SUPPL-31 Labeling

Label is not available on this site.

07/13/1981 SUPPL-30 Labeling

Label is not available on this site.

01/22/1981 SUPPL-28 Labeling

Label is not available on this site.

01/22/1981 SUPPL-27 Labeling

Label is not available on this site.

12/30/1982 SUPPL-26 Efficacy

Label is not available on this site.

07/08/1980 SUPPL-25 Labeling

Label is not available on this site.

07/08/1980 SUPPL-24 Labeling

Label is not available on this site.

07/08/1980 SUPPL-23 Labeling

Label is not available on this site.

02/11/1980 SUPPL-21 Labeling

Label is not available on this site.

01/17/1980 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1981 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/08/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1979 SUPPL-17 Labeling

Label is not available on this site.

03/16/1979 SUPPL-16 Labeling

Label is not available on this site.

02/01/1979 SUPPL-15 Labeling

Label is not available on this site.

12/04/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1978 SUPPL-13 Labeling

Label is not available on this site.

11/30/1978 SUPPL-12 Labeling

Label is not available on this site.

12/04/1978 SUPPL-10 Labeling

Label is not available on this site.

09/28/1978 SUPPL-9 Labeling

Label is not available on this site.

09/28/1978 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/16/1979 SUPPL-5 Labeling

Label is not available on this site.

03/16/1979 SUPPL-4 Efficacy

Label is not available on this site.

12/27/1977 SUPPL-3 Labeling

Label is not available on this site.

12/27/1977 SUPPL-1 Labeling

Label is not available on this site.

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