Application 019888
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;20MG | Yes | Yes |
| 002 | ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 25MG;20MG | Yes | Yes |
| 003 | ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;10MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52427-435 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-435 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-435 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-435 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-435 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-436 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-436 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-436 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-436 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-436 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-437 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-437 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-437 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-437 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
| 52427-437 | Zestoretic | lisinopril and hydrochlorothiazide | Almatica Pharma Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64351 | SUPPL | 2020-08-21 |
| 64343 | SUPPL | 2020-08-21 |
| 49070 | SUPPL | 2017-07-25 |
| 49047 | SUPPL | 2017-07-25 |
| 19796 | SUPPL | 2015-08-27 |
| 11819 | SUPPL | 2015-08-26 |
| 11818 | SUPPL | 2015-01-09 |
| 1778 | SUPPL | 2014-12-30 |
| 19795 | SUPPL | 2013-11-08 |
| 11817 | SUPPL | 2013-11-08 |
| 1776 | SUPPL | 2012-11-05 |
| 11816 | SUPPL | 2012-11-02 |
| 1777 | SUPPL | 2012-08-16 |
| 34075 | SUPPL | 2012-08-15 |
| 34073 | SUPPL | 2012-05-07 |
| 1774 | SUPPL | 2012-05-04 |
| 1775 | SUPPL | 2012-04-02 |
| 34074 | SUPPL | 2012-03-29 |
| 34072 | SUPPL | 2011-08-05 |
| 1773 | SUPPL | 2011-08-05 |
| 1772 | SUPPL | 2011-03-16 |
| 34071 | SUPPL | 2011-03-11 |
| 1771 | SUPPL | 2010-01-07 |
| 11815 | SUPPL | 2009-11-19 |
| 1770 | SUPPL | 2009-05-26 |
| 34070 | SUPPL | 2009-05-25 |
| 1769 | SUPPL | 2007-10-10 |
| 1768 | SUPPL | 2007-07-24 |
| 1767 | SUPPL | 2006-06-20 |
| 1766 | SUPPL | 2005-05-25 |
| 41076 | SUPPL | 2003-08-08 |
| 1765 | SUPPL | 2003-05-29 |
| 41075 | SUPPL | 2001-09-18 |