NDA 021993

BAYER HEALTHCARE LLC

FDA Drug Application

Application #021993

Documents

• Letter: 2008-10-23
• Letter: 2014-07-24
• Letter: 2006-12-14
• Letter: 2015-11-27
• Label: 2006-12-14
• Label: 2014-07-29
• Label: 2015-12-01
• Review: 2008-10-03
• Letter: 2018-07-25
• Label: 2018-08-03
• Letter: 2019-03-01
• Label: 2019-03-01

Application Sponsors

NDA 021993

BAYER HEALTHCARE LLC

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

5MG

1

CLARITIN REDITABS

LORATADINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2006-12-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2008-10-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-07-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-11-25	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-07-23	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-02-28	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21993
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITIN REDITABS","activeIngredients":"LORATADINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/28\/2019","submission":"SUPPL-17","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-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021993Orig1s016,020704Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/22\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/12\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021993s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLARITIN REDITABS","submission":"LORATADINE","actionType":"5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-02-28
        )

)