Documents
Application Sponsors
| NDA 022023 | MERCK AND CO INC | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | EMEND | FOSAPREPITANT DIMEGLUMINE |
| 002 | POWDER;INTRAVENOUS | EQ 150MG BASE/VIAL | 1 | EMEND | FOSAPREPITANT DIMEGLUMINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2008-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-03-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2010-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2010-03-23 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2016-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2013-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2014-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2015-01-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2016-12-02 | N/A |
| LABELING; Labeling | SUPPL | 15 | AP | 2017-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2017-08-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2018-04-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2019-11-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2022-05-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 8 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 21 | Null | 6 |
TE Codes
CDER Filings
MERCK AND CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22023
[companyName] => MERCK AND CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"EMEND","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 115MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"EMEND","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 150MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/14\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022023s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2018","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022023s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022023s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022023s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022023s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2016","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)-Manufacturing Process","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022023s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2016","submission":"SUPPL-6","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022023s006lbledt.pdf\"}]","notes":""},{"actionDate":"08\/12\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022023s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022023s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022023s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022023s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022023s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022023s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2010","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022023s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2010","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022023s002s003s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2010","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022023s002s003s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2010","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022023s002s003s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022023lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"EMEND","submission":"FOSAPREPITANT DIMEGLUMINE","actionType":"EQ 115MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"EMEND","submission":"FOSAPREPITANT DIMEGLUMINE","actionType":"EQ 150MG BASE\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-11-14
)
)