Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017920
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGAMET CIMETIDINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
TAGAMET CIMETIDINE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
TAGAMET CIMETIDINE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
TAGAMET CIMETIDINE 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
08/16/1977 ORIG-1 Approval Type 1 - New Molecular Entity 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
07/12/2006 SUPPL-95 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017920s095_ltr.pdf
12/14/2005 SUPPL-94 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017920s094ltr.pdf
07/29/1998 SUPPL-92 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1998 SUPPL-91 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1997 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1996 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

01/19/1996 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-87 Labeling

Label is not available on this site.

11/10/1993 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

09/29/1993 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1993 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

07/16/1992 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1992 SUPPL-81 Labeling

Label is not available on this site.

08/27/1992 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1991 SUPPL-78 Labeling

Label is not available on this site.

11/13/1989 SUPPL-77 Labeling

Label is not available on this site.

05/30/1990 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1991 SUPPL-74 Efficacy-New Indication

Label is not available on this site.

06/26/1989 SUPPL-73 Labeling

Label is not available on this site.

06/26/1989 SUPPL-72 Labeling

Label is not available on this site.

06/15/1988 SUPPL-69 Labeling

Label is not available on this site.

05/20/1988 SUPPL-68 Labeling

Label is not available on this site.

03/31/1988 SUPPL-67 Efficacy-New Dosing Regimen

Label is not available on this site.

04/29/1986 SUPPL-66 Efficacy-New Indication

Label is not available on this site.

04/23/1986 SUPPL-65 Labeling

Label is not available on this site.

01/13/1986 SUPPL-64 Labeling

Label is not available on this site.

12/18/1985 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

04/30/1986 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1985 SUPPL-61 Labeling

Label is not available on this site.

02/07/1985 SUPPL-59 Labeling

Label is not available on this site.

04/29/1986 SUPPL-57 Efficacy-New Dosing Regimen

Label is not available on this site.

09/26/1984 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1984 SUPPL-54 Labeling

Label is not available on this site.

07/19/1984 SUPPL-53 Labeling

Label is not available on this site.

03/22/1984 SUPPL-52 Labeling

Label is not available on this site.

03/05/1984 SUPPL-51 Labeling

Label is not available on this site.

09/23/1983 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/19/1984 SUPPL-48 Labeling

Label is not available on this site.

12/14/1983 SUPPL-47 Efficacy

Label is not available on this site.

02/28/1983 SUPPL-45 Labeling

Label is not available on this site.

01/31/1983 SUPPL-44 Efficacy

Label is not available on this site.

12/27/1984 SUPPL-43 Efficacy

Label is not available on this site.

01/04/1983 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1982 SUPPL-41 Efficacy

Label is not available on this site.

01/22/1982 SUPPL-38 Labeling

Label is not available on this site.

11/02/1981 SUPPL-37 Labeling

Label is not available on this site.

07/13/1981 SUPPL-36 Labeling

Label is not available on this site.

12/30/1982 SUPPL-35 Labeling

Label is not available on this site.

01/22/1981 SUPPL-32 Labeling

Label is not available on this site.

01/22/1981 SUPPL-31 Labeling

Label is not available on this site.

12/30/1982 SUPPL-30 Efficacy

Label is not available on this site.

06/02/1981 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/08/1980 SUPPL-28 Labeling

Label is not available on this site.

07/08/1980 SUPPL-27 Labeling

Label is not available on this site.

07/08/1980 SUPPL-26 Labeling

Label is not available on this site.

04/23/1980 SUPPL-24 Labeling

Label is not available on this site.

08/28/1981 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/07/1980 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1979 SUPPL-19 Labeling

Label is not available on this site.

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

Label is not available on this site.

04/23/1980 SUPPL-17 Efficacy

Label is not available on this site.

02/01/1979 SUPPL-16 Labeling

Label is not available on this site.

02/28/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1978 SUPPL-14 Labeling

Label is not available on this site.

11/30/1978 SUPPL-13 Labeling

Label is not available on this site.

09/28/1978 SUPPL-11 Labeling

Label is not available on this site.

09/28/1978 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/23/1980 SUPPL-8 Efficacy

Label is not available on this site.

03/16/1978 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/30/1977 SUPPL-4 Labeling

Label is not available on this site.

11/30/1977 SUPPL-3 Labeling

Label is not available on this site.

03/17/1978 SUPPL-1 Labeling

Label is not available on this site.

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