Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 12.5MG;20MG | 1 | ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL |
| 002 | TABLET;ORAL | 25MG;20MG | 1 | ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL |
| 003 | TABLET;ORAL | 12.5MG;10MG | 1 | ZESTORETIC | HYDROCHLOROTHIAZIDE; LISINOPRIL |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1989-07-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1990-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1990-11-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1990-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1991-02-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-04-08 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1991-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1991-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1992-06-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1992-11-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 1993-11-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 1993-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1994-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1993-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1995-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1993-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1994-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1994-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1994-09-15 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1995-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1995-03-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1995-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1995-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 1996-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1995-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1996-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1996-10-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1997-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 1998-05-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1999-11-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-07-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2000-12-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2000-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2001-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2003-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2002-10-17 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2005-05-24 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2006-06-16 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2007-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2007-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2009-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2009-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2011-03-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 50 | AP | 2011-08-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 51 | AP | 2012-05-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 52 | AP | 2012-03-29 | UNKNOWN |
| LABELING; Labeling | SUPPL | 53 | AP | 2012-10-31 | UNKNOWN |
| LABELING; Labeling | SUPPL | 54 | AP | 2012-08-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 55 | AP | 2013-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2014-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2015-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2017-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 47 | Null | 6 |
| SUPPL | 49 | Null | 6 |
| SUPPL | 50 | Null | 6 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 6 |
| SUPPL | 54 | Null | 7 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 15 |
| SUPPL | 65 | Null | 7 |
| SUPPL | 67 | Null | 7 |
| SUPPL | 69 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ALVOGEN
cder:Array
(
[0] => Array
(
[ApplNo] => 19888
[companyName] => ALVOGEN
[docInserts] => ["",""]
[products] => [{"drugName":"ZESTORETIC","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZESTORETIC","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"25MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZESTORETIC","activeIngredients":"HYDROCHLOROTHIAZIDE; LISINOPRIL","strength":"12.5MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019888s069lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2017","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019888s067lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2015","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019888s065lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2014","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019888s056lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2013","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019888s055lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2012","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019888s053lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2012","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019888s054lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2012","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019888s051lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2012","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019888s052lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019888s050lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2011","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019888s049lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019888s047lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2009","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019888s045lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZESTORETIC","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZESTORETIC","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"25MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZESTORETIC","submission":"HYDROCHLOROTHIAZIDE; LISINOPRIL","actionType":"12.5MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-08-20
)
)