ANDA 212581

TARO PHARM INDS LTD

FDA Drug Application

Application #212581

Documents

• Letter: 2021-05-06

Application Sponsors

ANDA 212581

TARO PHARM INDS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

AEROSOL, FOAM;TOPICAL

15%

0

AZELAIC ACID

AZELAIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212581
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELAIC ACID","activeIngredients":"AZELAIC ACID","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-19
        )

)