Drugs@FDA: FDA-Approved Drugs
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPOZIDE 25/15 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOZIDE 25/25 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOZIDE 50/15 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CAPOZIDE 50/25 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/12/1984 | 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 |
|---|---|---|---|---|---|
| 02/26/2009 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018709s035ltr.pdf |
| 05/16/2006 | SUPPL-33 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018709s033LTR.pdf |
| 05/20/1997 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1998 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 07/31/1996 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/06/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1993 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/1992 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/25/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/25/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/05/1992 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/10/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1990 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/21/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/27/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/03/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/19/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/22/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/06/1987 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1987 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/24/1991 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/02/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/15/1985 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/10/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1985 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/07/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |