Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075869
Company: TEVA
Company: TEVA
| 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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75869TA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/07/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/07/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/19/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/01/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/20/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/14/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |