Documents
Application Sponsors
Marketing Status
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
)
)