NDA 020470

BAYER HEALTHCARE LLC

FDA Drug Application

Application #020470

Documents

• Letter: 2004-07-21
• Label: 2004-08-02
• Review: 2007-03-02
• Letter: 2002-11-27
• Letter: 2003-07-06
• Letter: 2004-08-02
• Letter: 2010-02-17
• Letter: 2015-11-27
• Label: 2015-12-11
• Review: 1998-12-04
• Review: 2007-03-02
• Review: 2007-03-02
• Review: 2004-12-07
• Letter: 2018-08-03
• Label: 2018-08-03

Application Sponsors

NDA 020470

BAYER HEALTHCARE LLC

Marketing Status

• Over-the-counter: 002

Application Products

002

TABLET, EXTENDED RELEASE;ORAL

10MG;240MG

1

CLARITIN-D 24 HOUR

LORATADINE; PSEUDOEPHEDRINE SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-08-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	1997-10-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-01-30	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2002-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-12-09	STANDARD
LABELING; Labeling	SUPPL	19	AP	2003-06-25	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2004-07-30	UNKNOWN
LABELING; Labeling	SUPPL	23	AP	2004-07-15	STANDARD
LABELING; Labeling	SUPPL	34	AP	2010-01-25	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2013-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2013-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2014-01-03	STANDARD
LABELING; Labeling	SUPPL	44	AP	2015-11-25	STANDARD
LABELING; Labeling	SUPPL	47	AP	2018-07-31	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	22	Null	9
SUPPL	34	Null	7
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	6
SUPPL	47	Null	15

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20470
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITIN-D 24 HOUR","activeIngredients":"LORATADINE; PSEUDOEPHEDRINE SULFATE","strength":"10MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2018","submission":"SUPPL-47","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019670Orig1s034,020470Orig1s047Lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2015","submission":"SUPPL-44","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/30\/2004","submission":"SUPPL-22","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19670s019,20470s022lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLARITIN-D 24 HOUR","submission":"LORATADINE; PSEUDOEPHEDRINE SULFATE","actionType":"10MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-07-31
        )

)