Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075776
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/2002 | 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-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/17/2019 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/17/2019 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/17/2019 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2014 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2014 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/01/2010 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/28/2014 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/26/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |