SUN PHARM INDS INC FDA Approval ANDA 040870

ANDA 040870

SUN PHARM INDS INC

FDA Drug Application

Application #040870

Application Sponsors

ANDA 040870SUN PHARM INDS INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL5MG0METHIMAZOLEMETHIMAZOLE
002TABLET;ORAL10MG0METHIMAZOLEMETHIMAZOLE

FDA Submissions

ORIG1AP2007-09-25
LABELING; LabelingSUPPL7AP2016-01-15STANDARD
LABELING; LabelingSUPPL8AP2019-01-18STANDARD

Submissions Property Types

ORIG1Null1
SUPPL7Null7
SUPPL8Null7

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40870
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHIMAZOLE","activeIngredients":"METHIMAZOLE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHIMAZOLE","activeIngredients":"METHIMAZOLE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHIMAZOLE","submission":"METHIMAZOLE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHIMAZOLE","submission":"METHIMAZOLE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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