Drugs@FDA: FDA-Approved Drugs
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| CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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. |
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| 02/22/1995 | SUPPL-85 | Labeling |
Label is not available on this site. |
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| 11/10/1993 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/08/1993 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/16/1992 | SUPPL-81 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/07/1992 | SUPPL-80 | Labeling |
Label is not available on this site. |
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| 08/27/1992 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/13/1991 | SUPPL-77 | Efficacy-New Indication |
Label is not available on this site. |
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| 03/21/1990 | SUPPL-76 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/30/1990 | SUPPL-74 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/07/1991 | SUPPL-73 | Labeling |
Label is not available on this site. |
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| 06/26/1989 | SUPPL-72 | Labeling |
Label is not available on this site. |
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| 03/20/1989 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1989 | SUPPL-70 | Labeling |
Label is not available on this site. |
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| 06/15/1988 | SUPPL-68 | Labeling |
Label is not available on this site. |
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| 05/20/1988 | SUPPL-67 | Labeling |
Label is not available on this site. |
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| 11/13/1989 | SUPPL-66 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 06/03/1987 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1988 | SUPPL-64 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 07/24/1986 | SUPPL-63 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/23/1986 | SUPPL-61 | Labeling |
Label is not available on this site. |
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| 01/13/1986 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 05/15/1985 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 04/18/1985 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 02/07/1985 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 04/29/1986 | SUPPL-55 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 01/23/1985 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/18/1984 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 07/19/1984 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 07/11/1984 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/05/1984 | SUPPL-50 | Labeling |
Label is not available on this site. |
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| 03/05/1984 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 11/29/1983 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 07/19/1984 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 02/28/1984 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1983 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 01/31/1983 | SUPPL-41 | Efficacy |
Label is not available on this site. |
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| 04/22/1983 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1985 | SUPPL-39 | Efficacy-New Indication |
Label is not available on this site. |
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| 08/25/1982 | SUPPL-38 | Efficacy |
Label is not available on this site. |
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| 02/04/1982 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 01/22/1982 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 12/03/1981 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 12/30/1982 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 11/02/1981 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 07/13/1981 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 01/22/1981 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 01/22/1981 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 12/30/1982 | SUPPL-26 | Efficacy |
Label is not available on this site. |
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| 07/08/1980 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 07/08/1980 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 07/08/1980 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 02/11/1980 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 01/17/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/28/1981 | SUPPL-19 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/08/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/05/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/16/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 02/01/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/04/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/30/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 11/30/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 12/04/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 09/28/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/28/1978 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/16/1979 | SUPPL-4 | Efficacy |
Label is not available on this site. |
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| 12/27/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/27/1977 | SUPPL-1 | Labeling |
Label is not available on this site. |