Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019558
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRINIVIL | LISINOPRIL | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| PRINIVIL | LISINOPRIL | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| PRINIVIL | LISINOPRIL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| PRINIVIL | LISINOPRIL | 40MG | TABLET;ORAL | Discontinued | None | No | No |
| PRINIVIL | LISINOPRIL | 2.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1987 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/09/2021 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019558s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019558Orig1s063ltr.pdf | |
| 10/12/2018 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019558s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019558Orig1s062ltr.pdf | |
| 09/19/2017 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019558s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019558Orig1s061ltr.pdf | |
| 10/14/2016 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019558s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019558Orig1s060ltr.pdf | |
| 08/28/2015 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s059ltr.pdf | |
| 08/22/2014 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/2015 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s057ltr.pdf | |
| 02/26/2013 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019558Orig1s056ltr.pdf | |
| 06/07/2012 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf | |
| 11/17/2011 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf | |
| 06/10/2011 | SUPPL-53 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf |
| 10/09/2008 | SUPPL-52 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf |
| 10/09/2008 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf |
| 02/02/2007 | SUPPL-50 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf |
| 10/18/2006 | SUPPL-49 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf |
| 06/16/2006 | SUPPL-47 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf |
| 10/05/2005 | SUPPL-46 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019558s046ltr.pdf |
| 03/02/2004 | SUPPL-44 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf |
| 05/29/2003 | SUPPL-43 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-558S043_Prinivil.cfm | |
| 08/23/2001 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2001 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/2004 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr040ltr.pdf |
| 06/09/2000 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/15/1999 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1999 | SUPPL-36 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf |
| 09/03/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1995 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 06/26/1995 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/08/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1995 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 11/24/1995 | SUPPL-27 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/24/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/10/1994 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/23/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/28/1994 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 01/14/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/10/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/03/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/23/1992 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/09/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/06/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/07/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/14/1993 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/09/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/31/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/29/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/19/1988 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/25/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/09/2021 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019558s063lbl.pdf | |
| 10/12/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019558s062lbl.pdf | |
| 09/19/2017 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019558s061lbl.pdf | |
| 10/14/2016 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019558s060lbl.pdf | |
| 08/28/2015 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf | |
| 07/08/2015 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf | |
| 02/26/2013 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf | |
| 06/07/2012 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf | |
| 11/17/2011 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf | |
| 05/29/2003 | SUPPL-43 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf | |
| 12/29/1987 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf |