Documents
Application Sponsors
| NDA 020033 | US PHARMS HOLDINGS I | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
| 002 | TABLET;ORAL | 10MG;12.5MG | 1 | LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
| 003 | TABLET;ORAL | 20MG;25MG | 1 | LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
| 004 | TABLET;ORAL | 20MG;12.5MG | 1 | LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1992-05-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1992-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1992-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1993-10-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1993-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1995-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-04-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1997-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1997-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1998-07-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1999-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-10-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2001-12-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-08-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-04-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2003-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2007-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2008-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2009-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2009-11-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2011-03-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 41 | AP | 2011-06-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 43 | AP | 2012-02-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 45 | AP | 2012-01-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 46 | AP | 2012-07-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 47 | AP | 2012-09-21 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2014-07-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2014-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2014-12-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2015-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2015-08-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2016-02-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2016-06-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2016-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2017-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2018-08-08 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 43 | Null | 15 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 15 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 61 | Null | 6 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 63 | Null | 7 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20033
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)