Application 019558
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRINIVIL | LISINOPRIL | TABLET;ORAL | 5MG | No | No |
| 002 | PRINIVIL | LISINOPRIL | TABLET;ORAL | 10MG | No | No |
| 003 | PRINIVIL | LISINOPRIL | TABLET;ORAL | 20MG | No | No |
| 004 | PRINIVIL | LISINOPRIL | TABLET;ORAL | 40MG | No | No |
| 006 | PRINIVIL | LISINOPRIL | TABLET;ORAL | 2.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-0019 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0019 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0019 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0019 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0019 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0106 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0106 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0106 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0106 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0106 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0207 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0207 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0207 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0207 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-0207 | PRINIVIL | lisinopril | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69288 | SUPPL | 2021-11-10 |
| 69286 | SUPPL | 2021-11-10 |
| 55964 | SUPPL | 2018-10-17 |
| 55912 | SUPPL | 2018-10-15 |
| 49844 | SUPPL | 2017-09-22 |
| 49813 | SUPPL | 2017-09-20 |
| 45556 | SUPPL | 2016-10-19 |
| 45625 | SUPPL | 2016-10-17 |
| 33799 | SUPPL | 2015-09-03 |
| 17459 | SUPPL | 2015-09-01 |
| 11535 | SUPPL | 2015-07-13 |
| 1390 | SUPPL | 2015-07-13 |
| 11534 | SUPPL | 2013-03-01 |
| 1389 | SUPPL | 2013-02-28 |
| 11533 | SUPPL | 2012-06-11 |
| 1388 | SUPPL | 2012-06-08 |
| 17458 | SUPPL | 2011-11-21 |
| 11532 | SUPPL | 2011-11-21 |
| 1387 | SUPPL | 2011-06-17 |
| 17457 | SUPPL | 2008-10-14 |
| 1386 | SUPPL | 2008-10-14 |
| 1385 | SUPPL | 2007-02-12 |
| 1384 | SUPPL | 2006-10-23 |
| 17456 | SUPPL | 2006-06-20 |
| 44034 | ORIG | 2006-06-09 |
| 1383 | SUPPL | 2005-10-11 |
| 20263 | SUPPL | 2005-04-17 |
| 11530 | ORIG | 2004-06-14 |
| 1381 | ORIG | 2004-06-14 |
| 17454 | SUPPL | 2004-05-07 |
| 17455 | SUPPL | 2004-03-03 |
| 11531 | SUPPL | 2003-06-08 |
| 1382 | SUPPL | 2003-06-08 |
| 20262 | SUPPL | 2001-06-22 |