ANDA 206431

TARO PHARM INDS LTD

FDA Drug Application

Application #206431

Documents

• Letter: 2018-11-27

Application Sponsors

ANDA 206431

TARO PHARM INDS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;ORAL

1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

0

SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE

SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206431
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE","activeIngredients":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","strength":"1.6GM\/BOT;3.13GM\/BOT;17.5GM\/BOT","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206431Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-26
        )

)