SUN PHARM INDS INC FDA Approval ANDA 040790

ANDA 040790

SUN PHARM INDS INC

FDA Drug Application

Application #040790

Application Sponsors

ANDA 040790SUN PHARM INDS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL37.5MG0PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2007-08-21
LABELING; LabelingSUPPL6AP2012-12-06STANDARD
LABELING; LabelingSUPPL7AP2017-05-31STANDARD

Submissions Property Types

SUPPL6Null7
SUPPL7Null7

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40790
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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