Documents
Application Sponsors
| NDA 019625 | MERCK SHARP DOHME | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CREAM;TOPICAL | 0.1% | 0 | ELOCON | MOMETASONE FUROATE |
| 002 | CREAM;TOPICAL | 0.1% | 1 | ELOCON | MOMETASONE FUROATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1987-05-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1995-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-09-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-03-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-06-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-12-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2002-07-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2002-07-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2013-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2018-05-21 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 8 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 26 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 19625
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"ELOCON","activeIngredients":"MOMETASONE FUROATE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ELOCON","activeIngredients":"MOMETASONE FUROATE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/21\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019625s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-24","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019625s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19625s12s13lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19625s12s13lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ELOCON","submission":"MOMETASONE FUROATE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ELOCON","submission":"MOMETASONE FUROATE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-05-21
)
)