Documents
Application Sponsors
| NDA 020704 | BAYER HEALTHCARE LLC | |
Marketing Status
| Over-the-counter | 002 |
| Over-the-counter | 003 |
Application Products
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 1 | CLARITIN REDITABS | LORATADINE |
| 003 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 1 | CLARITIN HIVES RELIEF REDITAB | LORATADINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1996-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-09-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-09-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2002-11-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2003-11-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2006-01-19 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2008-10-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2009-01-29 | N/A |
| LABELING; Labeling | SUPPL | 27 | AP | 2014-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2015-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2016-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2017-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2018-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2019-02-28 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2019-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2021-01-11 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 37 | Null | 15 |
CDER Filings
BAYER HEALTHCARE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 20704
[companyName] => BAYER HEALTHCARE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"CLARITIN HIVES RELIEF REDITAB","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CLARITIN REDITABS","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/07\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020704Orig1s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2019","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020704Orig1s034,021993Orig1s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021993Orig1s016,020704Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020704Orig1s032lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2016","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020704Orig1s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2015","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/22\/2014","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CLARITIN HIVES RELIEF REDITAB","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CLARITIN REDITABS","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-05-07
)
)