Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074896
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET;ORAL | Prescription | None | No | No |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET;ORAL | Prescription | None | No | Yes |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET;ORAL | Prescription | None | No | No |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/29/1997 | 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-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/25/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |