Documents
Application Sponsors
| NDA 021067 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INHALATION | 0.22MG/INH | 1 | ASMANEX TWISTHALER | MOMETASONE FUROATE |
| 002 | POWDER;INHALATION | 0.11MG/INH | 1 | ASMANEX TWISTHALER | MOMETASONE FUROATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-03-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2008-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2008-02-26 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2010-09-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2015-08-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2016-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2018-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2018-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2019-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2021-02-16 | STANDARD |
Submissions Property Types
| SUPPL | 13 | Null | 6 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 32 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 21067
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"ASMANEX TWISTHALER","activeIngredients":"MOMETASONE FUROATE","strength":"0.22MG\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ASMANEX TWISTHALER","activeIngredients":"MOMETASONE FUROATE","strength":"0.11MG\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/19\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021067s029lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021067s026,s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021067s026,s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021067s026,s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021067s026,s028lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2010","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021067s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2008","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021067s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021067lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ASMANEX TWISTHALER","submission":"MOMETASONE FUROATE","actionType":"0.22MG\/INH","submissionClassification":"POWDER;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ASMANEX TWISTHALER","submission":"MOMETASONE FUROATE","actionType":"0.11MG\/INH","submissionClassification":"POWDER;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-12-19
)
)