Drugs@FDA: FDA-Approved Drugs
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLDOPA AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METHYLDOPA | 25MG;250MG | TABLET;ORAL | Discontinued | None | No | No |
METHYLDOPA AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METHYLDOPA | 15MG;250MG | TABLET;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 |
---|---|---|---|---|---|---|---|
01/23/1986 | ORIG-1 | Approval |
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-47 | Labeling-Package Insert |
Label is not available on this site. |
||
12/12/2005 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
09/05/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/02/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/24/1999 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
01/24/2000 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
06/16/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
02/25/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/27/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
06/20/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/29/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
09/26/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
06/20/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
01/31/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/20/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
01/25/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/07/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |