NDA 021717

TARO PHARMS

FDA Drug Application

Application #021717

Documents

• Letter: 2006-07-03
• Letter: 2013-11-12
• Label: 2006-07-03
• Letter: 2007-07-05
• Label: 2007-07-05
• Label: 2013-11-15
• Review: 2008-10-15
• Label: 2017-11-24
• Letter: 2017-11-27
• Label: 2018-11-05
• Letter: 2018-11-08
• Label: 2018-12-12
• Letter: 2018-12-20

Application Sponsors

NDA 021717

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

7%;7%

1

PLIAGLIS

LIDOCAINE; TETRACAINE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2006-06-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2007-06-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2013-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-11-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2018-12-11	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	5	Null	15
SUPPL	7	Null	0
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	11	Null	6

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21717
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PLIAGLIS","activeIngredients":"LIDOCAINE; TETRACAINE","strength":"7%;7%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/11\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021717s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021717s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021717s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021717s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021717s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021717s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2007","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021717s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021717lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PLIAGLIS","submission":"LIDOCAINE; TETRACAINE","actionType":"7%;7%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-11
        )

)