Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | EQ 5MG BASE;20MG | 1 | AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL |
| 002 | TABLET;ORAL | EQ 5MG BASE;40MG | 1 | AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL |
| 003 | TABLET;ORAL | EQ 10MG BASE;20MG | 1 | AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL |
| 004 | TABLET;ORAL | EQ 10MG BASE;40MG | 1 | AZOR | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2007-09-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2009-05-11 | UNKNOWN |
| LABELING; Labeling | SUPPL | 3 | AP | 2008-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2011-05-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-05-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 2011-11-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 14 | AP | 2011-11-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 16 | AP | 2012-01-18 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2013-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2012-09-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 20 | AP | 2012-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2013-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2014-05-14 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2014-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2014-07-02 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2014-09-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2015-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2015-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2016-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2016-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2016-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2017-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2020-10-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 39 | Null | 33 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
DAIICHI SANKYO
cder:Array
(
[0] => Array
(
[ApplNo] => 22100
[companyName] => DAIICHI SANKYO
[docInserts] => ["",""]
[products] => [{"drugName":"AZOR","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AZOR","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 5MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AZOR","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AZOR","activeIngredients":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","strength":"EQ 10MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022100s039lbl.pdf\"}]","notes":""},{"actionDate":"01\/05\/2017","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022100s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022100s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022100s026lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022100s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2014","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022100s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022100s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022100s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022100s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022100s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2011","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022100s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2011","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022100s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022100s010s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022100s010s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2009","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022100s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022100lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AZOR","submission":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","actionType":"EQ 5MG BASE;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AZOR","submission":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","actionType":"EQ 5MG BASE;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AZOR","submission":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","actionType":"EQ 10MG BASE;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AZOR","submission":"AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL","actionType":"EQ 10MG BASE;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-10-02
)
)