Documents
Application Sponsors
| NDA 022518 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | AEROSOL, METERED;INHALATION | 0.005MG/INH;0.1MG/INH | 1 | DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE |
| 002 | AEROSOL, METERED;INHALATION | 0.005MG/INH;0.2MG/INH | 1 | DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE |
| 003 | AEROSOL, METERED;INHALATION | 0.005MG/INH;0.05MG/INH | 1 | DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2010-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2011-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2011-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2012-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2012-11-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 7 | AP | 2012-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2013-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-01-25 | STANDARD |
| REMS; REMS | SUPPL | 10 | AP | 2012-11-27 | N/A |
| LABELING; Labeling | SUPPL | 11 | AP | 2013-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2013-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2013-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2014-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2015-04-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2015-08-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2015-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2015-12-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2016-07-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2016-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2017-06-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2017-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2018-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2018-03-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2019-08-12 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 26 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 22518
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"DULERA","activeIngredients":"FORMOTEROL FUMARATE; MOMETASONE FUROATE","strength":"0.005MG\/INH;0.1MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"DULERA","activeIngredients":"FORMOTEROL FUMARATE; MOMETASONE FUROATE","strength":"0.005MG\/INH;0.2MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"DULERA","activeIngredients":"FORMOTEROL FUMARATE; MOMETASONE FUROATE","strength":"0.005MG\/INH;0.05MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"08\/12\/2019","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022518s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022518s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022518s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022518s023s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2017","submission":"SUPPL-22","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022518s022lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022518s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2016","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022518s019,205641s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022518s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022518s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022518s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022518s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022518s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022518s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022518s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022518s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022518s002s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2011","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022518s002s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022518s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DULERA","submission":"FORMOTEROL FUMARATE; MOMETASONE FUROATE","actionType":"0.005MG\/INH;0.1MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DULERA","submission":"FORMOTEROL FUMARATE; MOMETASONE FUROATE","actionType":"0.005MG\/INH;0.2MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DULERA","submission":"FORMOTEROL FUMARATE; MOMETASONE FUROATE","actionType":"0.005MG\/INH;0.05MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-08-12
)
)