NDA 021056

BAUSCH

FDA Drug Application

Application #021056

Documents

• Letter: 2000-06-28
• Letter: 2011-04-13
• Label: 2011-04-11
• Review: 2001-07-12
• Label: 2000-06-28

Application Sponsors

NDA 021056

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

1%

1

TARGRETIN

BEXAROTENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-06-28	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2011-04-08	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-07-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2015-02-09	PRIORITY

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	3	Null	6
SUPPL	5	Null	14
SUPPL	6	Null	14

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21056
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARGRETIN","activeIngredients":"BEXAROTENE","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/08\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021056s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21056lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TARGRETIN","submission":"BEXAROTENE","actionType":"1%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-04-08
        )

)