Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CIMETIDINE HYDROCHLORIDE | EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/31/1985 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/15/1997 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/06/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 11/10/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/13/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/08/1993 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/23/1996 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/16/1992 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/07/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 08/27/1992 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/30/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/23/1991 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/13/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 11/13/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/30/1990 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/07/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/26/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/20/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 06/15/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/20/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/31/1988 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 04/29/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/23/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |