Drugs@FDA: FDA-Approved Drugs
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIURIL | CHLOROTHIAZIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| DIURIL | CHLOROTHIAZIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| DIURIL | CHLOROTHIAZIDE SODIUM | EQ 500MG BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/04/1958 | 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 |
|---|---|---|---|---|---|
| 03/20/2013 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/2005 | SUPPL-93 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037ltr.pdf |
| 10/22/2004 | SUPPL-92 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s092ltr.pdf |
| 09/23/2004 | SUPPL-91 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf |
| 09/23/2004 | SUPPL-90 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf |
| 11/08/2002 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1999 | SUPPL-88 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-87 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 11/29/1995 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1995 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 05/23/1995 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 03/16/1994 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 03/02/1993 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 02/16/1994 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 05/30/1989 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1993 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 03/02/1993 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 12/08/1986 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 01/13/1986 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 11/04/1985 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 10/11/1984 | SUPPL-61 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/1985 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/11/1984 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/24/1984 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 08/28/1984 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 08/30/1984 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1982 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1981 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/03/1981 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1981 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/08/1987 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 01/13/1981 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 01/13/1981 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 11/14/1980 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 07/13/1979 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 03/09/1979 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 07/31/1978 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 02/15/1978 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/02/1977 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/12/1976 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/1975 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/1975 | SUPPL-20 | Unspecified |
Label is not available on this site. |
||
| 03/27/1975 | SUPPL-19 | Unspecified |
Label is not available on this site. |