Drugs@FDA: FDA-Approved Drugs
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| TAGAMET | CIMETIDINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TAGAMET | CIMETIDINE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TAGAMET | CIMETIDINE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TAGAMET | CIMETIDINE | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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. |