ANDA 205971

TARO PHARM INDS LTD

FDA Drug Application

Application #205971

Documents

• Letter: 2018-08-20

Application Sponsors

ANDA 205971

TARO PHARM INDS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CREAM;TOPICAL

3.75%

0

IMIQUIMOD

IMIQUIMOD

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-07-31

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205971
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIQUIMOD","activeIngredients":"IMIQUIMOD","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205971Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-31
        )

)