Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076113
Company: MYLAN
Company: MYLAN
| 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/2002/76113tadF.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2018 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2018 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2018 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2018 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2018 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2014 | SUPPL-26 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2010 | SUPPL-19 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/04/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/23/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |