Documents
Application Sponsors
| NDA 021312 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | 1 | CLARINEX | DESLORATADINE |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG | 1 | CLARINEX | DESLORATADINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-06-26 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2003-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2004-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2006-12-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2005-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2006-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2006-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2010-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2012-11-14 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2014-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2019-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2019-03-15 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 0 |
| SUPPL | 11 | Null | 31 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 20 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 21312
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"CLARINEX","activeIngredients":"DESLORATADINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CLARINEX","activeIngredients":"DESLORATADINE","strength":"2.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/15\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021165s022,021300s019,021312s020,021563s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021165s020,021300s017,021312s018,021563s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021165s017,021300s014,021312s015,021563s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2006","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021312s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2005","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021312s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21312lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CLARINEX","submission":"DESLORATADINE","actionType":"5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CLARINEX","submission":"DESLORATADINE","actionType":"2.5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-15
)
)