NDA 020600

ALLERGAN

FDA Drug Application

Application #020600

Documents

• Letter: 2003-12-08
• Letter: 2011-03-02
• Label: 2011-03-04
• Letter: 2003-12-08
• Label: 2003-12-08
• Label: 2003-12-08
• Review: 2003-08-07
• Label: 2017-07-25
• Letter: 2017-07-25
• Label: 2018-04-17
• Letter: 2018-04-17

Application Sponsors

NDA 020600

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GEL;TOPICAL	0.05%	1	TAZORAC	TAZAROTENE
002	GEL;TOPICAL	0.1%	1	TAZORAC	TAZAROTENE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-06-17	STANDARD
LABELING; Labeling	SUPPL	3	AP	2003-12-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-12-02	STANDARD
LABELING; Labeling	SUPPL	8	AP	2011-02-25	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-07-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2018-04-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20600
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAZORAC","activeIngredients":"TAZAROTENE","strength":"0.05%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TAZORAC","activeIngredients":"TAZAROTENE","strength":"0.1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/16\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020600s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020600s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2011","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020600s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2003","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20600slr003,005_tazorac_lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2003","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20600slr003,005_tazorac_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TAZORAC","submission":"TAZAROTENE","actionType":"0.05%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TAZORAC","submission":"TAZAROTENE","actionType":"0.1%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-04-16
        )

)