NDA 019670

BAYER HEALTHCARE LLC

FDA Drug Application

Application #019670

Documents

• Letter: 2009-04-27
• Letter: 2010-02-17
• Letter: 2015-11-27
• Label: 2004-08-02
• Label: 2015-12-11
• Letter: 2002-11-27
• Letter: 2004-08-02
• Review: 2007-03-02
• Review: 2007-03-02
• Review: 2007-03-02
• Review: 2007-03-02
• Review: 2007-03-02
• Review: 2007-03-02
• Review: 2007-03-02
• Review: 2004-12-07
• Review: 2011-12-16
• Letter: 2018-08-03
• Label: 2018-08-03

Application Sponsors

NDA 019670

BAYER HEALTHCARE LLC

Marketing Status

• Over-the-counter: 002

Application Products

002

TABLET, EXTENDED RELEASE;ORAL

5MG;120MG

1

CLARITIN-D

LORATADINE; PSEUDOEPHEDRINE SULFATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1994-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-09-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	1996-04-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	1997-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-07-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	1997-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-01-27	STANDARD
LABELING; Labeling	SUPPL	10	AP	1998-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-03-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-03-04	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2002-11-27	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	2004-07-30	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2009-04-23	N/A
LABELING; Labeling	SUPPL	22	AP	2010-01-25	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2013-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	32	AP	2015-11-25	STANDARD
LABELING; Labeling	SUPPL	34	AP	2018-07-31	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	9
SUPPL	22	Null	6
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	15
SUPPL	34	Null	15

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19670
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITIN-D","activeIngredients":"LORATADINE; PSEUDOEPHEDRINE SULFATE","strength":"5MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2018","submission":"SUPPL-34","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-32","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/30\/2004","submission":"SUPPL-19","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","submission":"LORATADINE; PSEUDOEPHEDRINE SULFATE","actionType":"5MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-07-31
        )

)