Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076430
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76430ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/02/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/22/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/22/2015 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/08/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |