Documents
Application Sponsors
| NDA 021313 | MERCK SHARP DOHME | |
Marketing Status
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 2.5MG;120MG | 1 | CLARINEX-D 12 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2006-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-03-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-03-15 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 21313
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"CLARINEX-D 12 HOUR","activeIngredients":"DESLORATADINE; PSEUDOEPHEDRINE SULFATE","strength":"2.5MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/15\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021313s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021313s010,021605s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021313s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021313s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021313s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2007","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021313s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021313s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CLARINEX-D 12 HOUR","submission":"DESLORATADINE; PSEUDOEPHEDRINE SULFATE","actionType":"2.5MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-15
)
)