Documents
Application Sponsors
| NDA 019658 | BAYER HEALTHCARE LLC | |
Marketing Status
| Over-the-counter | 002 |
| Over-the-counter | 003 |
Application Products
| 002 | TABLET;ORAL | 10MG | 1 | CLARITIN | LORATADINE |
| 003 | TABLET;ORAL | 10MG | 1 | CLARITIN HIVES RELIEF | LORATADINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-04-12 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1993-09-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1995-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-02-09 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1995-10-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-09-01 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1997-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1998-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-05-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1999-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-07-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2002-11-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-12-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2003-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2003-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2007-12-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2012-11-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2013-06-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2015-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2015-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2016-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2016-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2017-04-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2018-01-12 | N/A |
| LABELING; Labeling | SUPPL | 51 | AP | 2018-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2018-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2018-07-05 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2018-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2018-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2019-02-06 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 15 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 7 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 52 | Null | 15 |
| SUPPL | 53 | Null | 6 |
| SUPPL | 54 | Null | 7 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 15 |
CDER Filings
BAYER HEALTHCARE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 19658
[companyName] => BAYER HEALTHCARE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"CLARITIN","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CLARITIN HIVES RELIEF","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/06\/2019","submission":"SUPPL-56","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019658Orig1s056lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2018","submission":"SUPPL-55","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019658Orig1s055,021952Orig1s018Lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2018","submission":"SUPPL-54","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019658Orig1s054lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2018","submission":"SUPPL-53","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019658Orig1s053lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2018","submission":"SUPPL-52","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019658Orig1s052lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2018","submission":"SUPPL-51","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019658Orig1s051lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2017","submission":"SUPPL-48","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019658Orig1s048lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2016","submission":"SUPPL-46","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019658Orig1s046lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2016","submission":"SUPPL-46","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019658Orig1s046lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2016","submission":"SUPPL-45","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019658Orig1s045lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2015","submission":"SUPPL-44","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019658Orig1s044lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2007","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019658s026lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CLARITIN","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CLARITIN HIVES RELIEF","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-02-06
)
)