Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MAVIK | TRANDOLAPRIL |
| 002 | TABLET;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MAVIK | TRANDOLAPRIL |
| 003 | TABLET;ORAL | 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MAVIK | TRANDOLAPRIL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1996-04-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-09-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-07-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2001-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2004-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2010-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2009-04-08 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2011-11-10 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2012-01-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 19 | AP | 2011-09-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 20 | AP | 2012-01-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 21 | AP | 2012-09-11 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2013-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2014-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2016-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2017-08-02 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 20528
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"MAVIK","activeIngredients":"TRANDOLAPRIL","strength":"1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MAVIK","activeIngredients":"TRANDOLAPRIL","strength":"2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MAVIK","activeIngredients":"TRANDOLAPRIL","strength":"4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/02\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020528s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2016","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020528s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020528s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020528s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020528s020,020591s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020528s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020528s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2010","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020528s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2009","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020528s016lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MAVIK","submission":"TRANDOLAPRIL","actionType":"1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MAVIK","submission":"TRANDOLAPRIL","actionType":"2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MAVIK","submission":"TRANDOLAPRIL","actionType":"4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-08-02
)
)