ELITE LABS INC FDA Approval ANDA 040460

ANDA 040460

ELITE LABS INC

FDA Drug Application

Application #040460

Application Sponsors

ANDA 040460ELITE LABS INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL15MG0PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2003-01-14
LABELING; LabelingSUPPL6AP2017-05-31STANDARD

Submissions Property Types

SUPPL6Null15

CDER Filings

ELITE LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40460
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.