NDA 021952

BAYER HEALTHCARE LLC

FDA Drug Application

Application #021952

Documents

• Letter: 2008-06-19
• Letter: 2009-04-10
• Letter: 2015-12-10
• Summary Review: 2008-07-17
• Label: 2015-12-11
• Review: 2009-08-27
• Letter: 2018-04-23
• Label: 2018-04-23
• Letter: 2018-06-05
• Label: 2018-06-06
• Letter: 2018-06-27
• Label: 2018-07-04
• Letter: 2018-07-23
• Label: 2018-08-03
• Label: 2018-12-27
• Letter: 2018-12-31

Application Sponsors

NDA 021952

BAYER HEALTHCARE LLC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

10MG

1

CLARITIN

LORATADINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2008-06-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2009-04-06	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-12-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-06-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-06-20	STANDARD
LABELING; Labeling	SUPPL	17	AP	2018-07-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-12-21	STANDARD

Submissions Property Types

SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	6
SUPPL	16	Null	6
SUPPL	17	Null	6
SUPPL	18	Null	7

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21952
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITIN","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019658Orig1s055,021952Orig1s018Lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021952Orig1s017Lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021952Orig1s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021952Orig1s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021952Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/09\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021952Orig1s012lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLARITIN","submission":"LORATADINE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)