NDA 020774

DEXCEL PHARMA

FDA Drug Application

Application #020774

Documents

• Letter: 1998-05-15
• Letter: 2011-06-14
• Letter: 2012-11-09
• Label: 1998-05-15
• Label: 2011-07-07
• Label: 2012-11-08
• Review: 1998-05-15
• Letter: 2002-12-15
• Letter: 2004-03-03
• Letter: 2012-01-17
• Label: 2002-12-15
• Label: 2004-04-05
• Label: 2012-01-23

Application Sponsors

NDA 020774

DEXCEL PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;DENTAL

2.5MG

1

PERIOCHIP

CHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-06-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-03-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-02-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2004-03-02	STANDARD
LABELING; Labeling	SUPPL	10	AP	2011-06-08	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2012-01-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2012-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-07-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	6
SUPPL	13	Null	0

CDER Filings

DEXCEL PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20774
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERIOCHIP","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"2.5MG","dosageForm":"TABLET;DENTAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/08\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020774s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020774s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2011","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020774Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2004","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20774slr007_periochiop_lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2002","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20774slr003_perioChip_lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20774lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PERIOCHIP","submission":"CHLORHEXIDINE GLUCONATE","actionType":"2.5MG","submissionClassification":"TABLET;DENTAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-11-08
        )

)