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| CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | No | No |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 2 - New Active Ingredient | 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-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/22/1995 | SUPPL-58 | Labeling |
Label is not available on this site. |
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11/10/1993 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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06/08/1993 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1992 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/07/1992 | SUPPL-53 | Labeling |
Label is not available on this site. |
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08/27/1992 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/13/1991 | SUPPL-50 | Labeling |
Label is not available on this site. |
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11/13/1989 | SUPPL-49 | Labeling |
Label is not available on this site. |
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05/30/1990 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/07/1991 | SUPPL-46 | Labeling |
Label is not available on this site. |
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06/26/1989 | SUPPL-45 | Labeling |
Label is not available on this site. |
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06/26/1989 | SUPPL-44 | Labeling |
Label is not available on this site. |
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06/15/1988 | SUPPL-42 | Labeling |
Label is not available on this site. |
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05/20/1988 | SUPPL-41 | Labeling |
Label is not available on this site. |
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03/31/1988 | SUPPL-40 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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04/23/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
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01/13/1986 | SUPPL-37 | Labeling |
Label is not available on this site. |
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05/15/1985 | SUPPL-36 | Labeling |
Label is not available on this site. |
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04/18/1985 | SUPPL-35 | Labeling |
Label is not available on this site. |
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02/07/1985 | SUPPL-34 | Labeling |
Label is not available on this site. |
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04/29/1986 | SUPPL-33 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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06/14/1984 | SUPPL-32 | Labeling |
Label is not available on this site. |
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07/19/1984 | SUPPL-31 | Labeling |
Label is not available on this site. |
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12/05/1984 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/05/1984 | SUPPL-29 | Labeling |
Label is not available on this site. |
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07/19/1984 | SUPPL-27 | Labeling |
Label is not available on this site. |
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02/28/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
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01/31/1983 | SUPPL-24 | Efficacy |
Label is not available on this site. |
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03/11/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1982 | SUPPL-22 | Efficacy |
Label is not available on this site. |
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01/22/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
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12/30/1982 | SUPPL-18 | Labeling |
Label is not available on this site. |
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11/02/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
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07/13/1981 | SUPPL-16 | Labeling |
Label is not available on this site. |
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06/12/1981 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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01/22/1981 | SUPPL-13 | Labeling |
Label is not available on this site. |
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01/22/1981 | SUPPL-12 | Labeling |
Label is not available on this site. |
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12/30/1982 | SUPPL-11 | Efficacy |
Label is not available on this site. |
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07/08/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/08/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |