ANDA 200173

TARO

FDA Drug Application

Application #200173

Application Sponsors

ANDA 200173

TARO

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

5%

0

IMIQUIMOD

IMIQUIMOD

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2011-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-08-29	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200173
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIQUIMOD","activeIngredients":"IMIQUIMOD","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/29\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-08-29
        )

)