Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DYAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | No | No |
| DYAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/02/1965 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016042s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/016042Orig1s079ltr.pdf | |
| 03/15/2011 | SUPPL-78 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016042s078ltr.pdf | |
| 02/23/2010 | SUPPL-77 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016042s077ltr.pdf | |
| 05/18/2007 | SUPPL-74 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016042s074ltr.pdf |
| 12/20/2000 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2001 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1998 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1994 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 05/20/1994 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1994 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 05/01/1992 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1991 | SUPPL-61 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/23/1988 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1986 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 03/07/1985 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 03/03/1994 | SUPPL-55 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/13/1983 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1985 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 10/08/1982 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 08/25/1982 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 10/30/1981 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 02/23/1982 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 07/14/1980 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 01/14/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 12/06/1979 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 02/02/1981 | SUPPL-40 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/18/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 09/18/1979 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 09/18/1979 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/19/1978 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1978 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 02/22/1978 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 02/22/1978 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 02/22/1978 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/14/1977 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/14/1977 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/12/1977 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/03/1976 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/21/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/21/1976 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/27/1976 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/12/1975 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/23/1976 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/27/1975 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/27/1975 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/27/1976 | SUPPL-14 | Unspecified |
Label is not available on this site. |
||
| 06/23/1976 | SUPPL-8 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016042s079lbl.pdf | |
| 03/15/2011 | SUPPL-78 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf | |
| 02/23/2010 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf |