ELITE LABS INC FDA Approval ANDA 040448

ANDA 040448

ELITE LABS INC

FDA Drug Application

Application #040448

Application Sponsors

ANDA 040448ELITE LABS INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL30MG0PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2003-01-22
LABELING; LabelingSUPPL4AP2017-05-31STANDARD

Submissions Property Types

SUPPL4Null7

CDER Filings

ELITE LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40448
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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