Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075752
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISINOPRIL | LISINOPRIL | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 30MG | TABLET;ORAL | Discontinued | None | No | No |
| LISINOPRIL | LISINOPRIL | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75752ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2016 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2015 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2015 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2015 | 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-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/22/2010 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/05/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/17/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/29/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |